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 FDA NEWS RELEASE 
 
 For Immediate Release: Sept. 22, 2009 
 
 Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov 
 
 Consumer Inquiries: 1-888-INFO-FDA 
 
 FDA: Philips Lifeline Issues Safety Alert for Lifeline Pendant Personal Help Buttons 
 
 The U.S. Food and Drug Administration today cautioned users of personal emergency response buttons worn around the neck of a potential choking hazard associated with this product. 
 
 The FDA is aware of at least six reports between 1998 and 2009 of serious injury or death, including three deaths in the United States and one in Canada, from choking after the cord on the Philips Lifeline Personal Help Button became entangled on other objects worn around the neck. 
 
 There are more than 750,000 users of these devices in the United States and Canada. By pushing the “help” button on the device when in distress, users can call for emergency assistance to their home. According to Philips Lifeline, the device is used primarily by seniors living independently, who feel they are at risk for falls or other medical emergencies. 
 
 The Lifeline pendant button is intentionally designed to not break away when tugged, which prevents the button from accidentally falling off. However, because it does not break away, there is a risk of choking, including the possibility of serious injury or death. Risks are greater for those with mobility limitations or for those who use wheelchairs, walkers, beds with guard rails, or other objects that could entangle with a neck cord. 
 
 Philips Lifeline is currently sending letters to its 750,000 customers and has changed the labeling of this product to include a warning against the potential choking hazard. 
 
 The FDA recommends that users consult their health care providers to determine which style of emergency button, including those that are worn on the wrist, is most beneficial for them. 
 
 These widely used devices provide critical and immediate access to emergency care for those at risk of falls or who may be more likely to need outside assistance. While the number of adverse events reported is small compared to the number of people who use this device, the severity of these events is of concern. It remains important that users, along with their health care providers, assess the options provided by each style of button, and choose the option that best fits their condition. 
 
 Health care professionals and users may report serious adverse events or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone. 
 
 Online: www.fda.gov/MedWatch/report.htm 
 
 Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD, 20852-9787 
 
 Fax: (800) FDA-0178 
 
 Phone: (800) FDA-1088 
 
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 - ||||| Roseann J. DiFrancesco, 86, of New Cumberland, died on Friday, February 12, 2016 in her home.She was a retired employee of the Federal Government with 25 years of service and a retired Clerk for the PA Dept. of Labor & Industry with 18 years of service; a member of the former St. Ann Roman Catholic Church, Steelton, and a member of Prince of Peace Roman Catholic Parish, Steelton.Roseann was the daughter of the late Antonio and Adelina Buccieri DiFrancesco and is survived by two sisters, Dolores D. Fitting of Steelton and Juanita T. Roberts and her husband, Richard A. of New Cumberland; one brother, Dominic D. DiFrancesco of Middletown; and numerous nieces and nephews.Private Graveside and Burial Services were held at the convenience of the family in Resurrection Cemetery with Very Rev. Robert M. Gillelan, Jr., VG officiating. Arrangements are being handled by Wiedeman Funeral Home, Steelton.In lieu of flowers, memorial contributions may be made to Daughters of our Lady of Mercy, 1009 Main Rd., Newfield, NJ 08344-5348. ||||| An 86-year-old New Cumberland woman died after she tripped and her medical alert necklace caught on her walker and strangled her. 
 
 Roseann J. DiFrancesco was found dead in her bathroom on Feb. 15, according to the report from the Cumberland County Coroner's Office. Relatives had last spoken to her on Feb. 12. 
 
 She was found after a visiting nurse, unable to summon DiFranceso by knocking on the door, entered her home and found her. It was unclear how long she had been dead. 
 
 Cumberland County Coroner Charles Hall said the lanyard of the medical device, having caught on the walker, caused DiFrancesco's upper torso to be suspended above the floor level, and the resulting pressure on her neck cut off air and blood flow. 
 
 Hall said the lanyard used by DiFrancesco apparently lacked a breakaway feature. But he didn't know whether it was the lanyard that came with the device or a replacement. 
 
 Hall called the death a "freak accident." 
 
 However, there have been injuries and a few deaths associated with such personal alert systems over the years. In 2009, the U.S. Food and Drug Administration issued a warning, saying it was aware of at least six serious injuries or deaths related to one of the popular brands of the device between 1998 and 2009. 
 
 Available from numerous makers, they often involve a pendant with a button the wearer can push to summon medical help in the event of a fall or medical emergency. 
 
 Some have break-away lanyards to prevent choking or injury if the lanyard catches on something or is otherwise pulled. 
 
 However, there has been disagreement over the benefits of breakaway lanyards, with some device makers saying the greater danger is that a lanyard will break and the alert device will be out of reach when needed. 
 
 The FDA said the risks of a non-breakaway lanyards are greatest for people such as those who use wheelchairs, walkers or beds with rails. 
 
 Noting that some alert devices can be worn around the wrist, the FDA advised people to consult a health care provider to determine which type of device is most appropriate. 
 
 The FDA wrote, "These widely used devices provide critical and immediate access to emergency care for those at risk of falls or who may be more likely to need outside assistance. While the number of adverse events reported is small compared to the number of people who use this device, the severity of these events is of concern. It remains important that users, along with their health care providers, assess the options provided by each style of button, and choose the option that best fits their condition." 
 
 Note: This story was edited to remove the slogan of one the companies that manufactures personal alert systems. The Cumberland County Coroner said he didn't know the brand of the device used by Roseann DiFrancesco. ||||| × 86-year-old woman accidentally hangs herself with medical alert necklace 
 
 CUMBERLAND COUNTY, Pa. – An 86-year-old Cumberland County woman is dead after she trips and is accidentally hanged by her medical alert necklace. It happened on February 15. 
 
 County Coroner Charles Hall says Roseann DiFrancesco was found dead in her bathroom by a visiting nurse who entered the home after getting no response after knocking. 
 
 Hall says DiFrancesco was using her walker when she lost her balance and fell. Her medical alert necklace got caught on the handle of the walker. She was left hanging by the necklace which led to her death. 
 
 Her death has been ruled accidental. 
 
 Medical alert devices are quite common. Most are worn suspended by a necklace. Hall says DiFrancesco’s necklace did not have a break away clasp.
– In what the Cumberland County, Penn., coroner is calling a "freak accident," an 86-year-old woman was strangled to death by a device that was intended to save her life. Roseann J. DiFrancesco apparently tripped and fell, causing her medical alert necklace to become caught on her walker, the Patriot-News reports. The result, says Coroner Charles Hall, was that her upper torso was suspended above the floor, creating pressure on her neck that cut off air and blood flow. Relatives had last spoken to DiFrancesco on Feb. 12. A visiting nurse found the woman dead in her bathroom Feb. 15, when the nurse entered DiFrancesco's home after unsuccessful attempts to summon her by knocking on the door. It is unclear when DiFrancesco died. Her death was ruled an accident, Fox 43 reports. The device (similar to the ones popularized by "I've fallen and I can't get up" commercials) did not have a breakaway lanyard, as some do, per the Patriot-News. The FDA has warned of potential choking with such devices, which typically include a pendant with a button to call for help, saying the agency is aware of at least six serious injuries or deaths related to their use between 1998 and 2009. "Risks are greater for those with mobility limitations or for those who use wheelchairs, walkers, beds with guard rails, or other objects that could entangle with a neck cord," the FDA says in a press release. DiFrancesco, who was retired, had worked for 25 years for the federal government and 18 years for the state, according to an obituary. (A freak accident claimed the life of a pregnant woman in Oregon this week.)