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:6/27/2016)... ... 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to Best Buy ... in the United States and Canada wear eyeglasses. Once considered to be a purely ... make a fashion statement. Even celebrities use glasses as a way of creating an ...
(Date:6/26/2016)... ... ... Kasmer, a legally blind and certified personal trainer is helping to develop a weight loss ... plans to fix the two major problems leading the fitness industry today:, ... , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... California (PRWEB) , ... June 25, 2016 , ... "With ... fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... customizable and all within Final Cut Pro X . Simply select a ProHand ...
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... June 24, 2016 , ... The ... in Dallas that it will receive two significant new grants to support its ... PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists for ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ., ... developing innovative inhaled drugs, announced today that it was ... Investments reconstituted its comprehensive set of U.S. and ... "This is an important milestone for Pulmatrix," said Chief ... shareholder awareness of our progress in developing drugs for ...
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, ... Global Forecast to 2021" report to their offering. ... pharmaceutical excipients market is projected to reach USD 8.1 ... the forecast period 2016 to 2021. ...
Breaking Medicine Technology: