Navigation Links
FDA: Philips Lifeline Issues Safety Alert for Lifeline Pendant Personal Help Buttons
Date:9/22/2009

SILVER SPRING, Md., Sept. 22 /PRNewswire-USNewswire/ -- 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

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

    Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
    Consumer Inquiries: 1-888-INFO-FDA



'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. MEDRAD Announces eCoil(TM) for Siemens, Philips 3.0T MR Scanners
2. Audio from Medialink and Philips: Americas Dirty Mouths
3. AUDIO from Medialink and Philips: Getting Rid of the Uninvited Holiday Guests on Your Toothbrush
4. North Carolina Coalition on Donation Selects Corder Philips for Newest Campaign
5. Royal Philips Electronics to Acquire Respironics for USD $66.00 Per Share
6. VIDEO from Medialink and Philips: Philips Electronics Unveils First Imagination Light Canvas at the New Mercy Medical Center in Rogers AR
7. Philips Supports the Boston Marathon as the Sole Provider of Life-Saving Medical Devices
8. AUDIO from Medialink, Oral Health America & Philips Sonicare: National Smile Month - Giving Americans Something to Smile About Survey Reveals State of Americans Oral Health
9. Philips Web Site Offers Seniors and Caregivers Tips and Techniques for Preventing Falls
10. Craig W. Philips Takes Helm at CTI
11. VIDEO from Medialink and Philips: Microbubbles Developed to Administer Medications That Fight Cancer and Reduce Side Effects
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/21/2017)... ... 2017 , ... Young Asset Protection, an insurance provider and ... greater Pittsburgh metropolitan region, is joining forces with the local chapter of the ... , Variety the Children’s Charity is a national organization dedicated to empowering, enabling, ...
(Date:4/21/2017)... ... April 21, 2017 , ... The Hong Kong Polytechnic University (PolyU) ... facility among higher education institutions in Hong Kong to support teaching, learning and research. ... range and quantity of facilities in Hong Kong. , With an area of ...
(Date:4/21/2017)... CA (PRWEB) , ... April 21, 2017 , ... ... Joseph Health held the much anticipated Regional Primary Care Spring Symposium on April ... in the local medical community, offering physicians and healthcare providers an opportunity to ...
(Date:4/21/2017)... CA (PRWEB) , ... April 21, 2017 , ... ... to experienced, personalized dental care since 1985. After thirty-two years, Dr. Latner has become ... privilege to help my numerous clients over the years with all their dental needs,” ...
(Date:4/21/2017)... , ... April 21, 2017 , ... ... Detroit reveals good news for older shoulder replacement patients; post-operative recovery just might ... from two groups of patients presenting with osteoarthritis following surgery: 262 patients under ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 2017 Research and Markets has announced the ... by Rapidly Expanding Injectables Market and Increasing Usage of Complex Biologics ... ... will rise from USD 20 Billion in 2015 to around USD ... Technologies - Innovation Driven by Rapidly Expanding Injectables Market and Increasing ...
(Date:4/20/2017)... 2017 Eyevensys, a private biotechnology ... gene expression technology that enables the safe, local, sustained ... a wide range of ophthalmic diseases, announces it has ... Regulatory Agency (MHRA) to advance its technology into clinical ... The ...
(Date:4/19/2017)... The Mobile X-Ray product segment is the most ... the forecast period Mobile X-Ray segment is the ... X-Ray devices market, which is estimated to be valued at ... CAGR of 7% over the forecast period. Mobile X-Ray segment ... US$ 100 Mn in 2017 over 2016. The segment,s revenue ...
Breaking Medicine Technology: