HEAVY DUTY ROLLATOR

Additional Manufacturer Narrative

BASED ON THE SUPPLIER¿S INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD HAVE LED TO THE REPORTED INCIDENT. THE SUPPLIER REVIEWED THE DEVICE MASTER RECORD AND THERE WERE NO DESIGN CHANGES, PRODUCTION PROCESS CHANGES OR MATERIAL CHANGES. THEY RECEIVED AND REVIEWED PHOTOS AND OBSERVED THAT THE RIGHT FRONT WHEEL OF THE ROLLATOR IS SEPARATED FROM THE MAIN BODY AND BROKEN FROM THE FIXED BOLT POSITION. AS THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR FURTHER INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION THE COMPLAINT INVESTIGATION WILL BE REOPENED.

Description of Event or Problem

THE PATIENTS¿ DAUGHTER, (B)(6) CALLED, CLAIMING THE WHEEL ON THE ROLLATOR REPORTEDLY BROKE AND SUBSEQUENTLY THE PATIENT FELL, BUT HE WAS NOT INJURED. SHE REPORTED THAT HER FATHER WEIGHS LESS THAN 350 POUNDS, BUT PROVIDED NO OTHER INFORMATION.