MEDLINE ALUMINUM QUAD CANE WITH LARGE BASE OFFSET HANDLE 300LBS BLACK 1CT

Description of Event or Problem

CANE BROKE DURING USE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT A FALL OCCURRED DUE TO THE CANE BREAKING. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW-UP CARE. IT HAS BEEN DETERMINED THAT THE EVENT DID NOT INVOLVE A DEATH OR SERIOUS INJURY; HOWEVER, IT MEETS THE DEFINITION OF A REPORTABLE MALFUNCTION, AS RECURRENCE OF THE MALFUNCTION COULD CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.