FDA issues safety alert for personal emergency-response buttons worn around the neck

The Food and Drug Administration issued a warning Tuesday to users of personal emergency-response buttons worn around the neck that they present a potential choking hazard.

The agency said it is aware of at least six reports between 1998 and 2009 of serious injury or death — with three deaths in the United States and one in Canada — from choking that occurred when the cord on the button became entangled with other objects.

There are more than 750,000 of the devices — the Philips Lifeline Personal Help Buttons — in the United States and Canada, the company said. Of them, 572,000 are worn around the neck, said Steve Kelly, director of public relations for Philips Health Care. Wearers can call for emergency help to their home by pushing the monitored device’s “help” button.

He said the pendant button is designed not to break away when pulled to ensure it does not fall off by accident. But that same attribute increases the risk that, if it were to catch onto a wheelchair, walker, bed with guard rails or other object, that it could choke the wearer.

On the company’s Web site, a note cautions about the choking risk. “Wearers for whom this is a concern may wish to consider the Wrist Style method,” it says. Kelly said Philips Lifeline is sending letters to its customers and has changed the device’s labeling to include a warning.