inforMED

HUGO

Received Aug 17, 2016 · Event occurred Apr 26, 2016

Report 8022077-2016-00057 · MDR key 5884250

Device

Generic name

Elite Rolling Walker With A Seat

Manufacturer

Amg Medical Inc.

Model number

700-959

Product problems

  • Break

Patient

87 YR

  • Fall
  • Fall

Narrative

Additional Manufacturer Narrative

THIS IS THE FIRST TIME WE HAVE AN ISSUE OF THE SORT OF THE SHORT GREY METAL TUBE INSIDE THE REAR RIGHT LEG BREAKING IN HALF. THIS IS AN ISOLATED OCCURRENCE. WE WILL MONITOR THIS CLOSELY BUT FOR NOW THIS IS THE FIRST INCIDENT OF THE SORT. WE SENT THE CUSTOMER A NEW REPLACEMENT UNIT. THE BROKEN UNIT WAS NEVER SENT HERE FOR INVESTIGATION. THIS CASE IS NOW CLOSED.

Description of Event or Problem

THE SHORT GREY METAL TUBE INSIDE THE REAR RIGHT LEG BROKE IN HALF. THE CUSTOMER WAS WALKING, SHE FELL BUT NO INJURY.