CANE, QUAD, SMALL BASE, BRONZE

Additional Manufacturer Narrative

REPORTEDLY, THE END-USER HAS CAUGHT THE QUAD CANE IN REVOLVING DOORS IN THE PAST AND THE DEVICE TYPICALLY LEANS TO THE SIDE. ON THE DATE OF THE INCIDENT, THE QUAD CANE "TWISTED COMPLETELY" AS THE END-USER WAS WALKING AND SHE EXPERIENCED A FALL. THE END-USER WAS ABLE TO GET HERSELF BACK UP AFTER THE FALL AND SHE WENT TO HER LOCAL HOSPITAL'S EMERGENCY DEPARTMENT (ED). UNIDENTIFIED DIAGNOSTIC EXAMS WERE PERFORMED AND THE END-USER STATED THAT SHE WAS TOLD THAT SHE DID NOT EXPERIENCE A FRACTURE. NO ED MEDICAL TREATMENTS WERE REPORTED TO THE MANUFACTURER. THE END-USER WAS DISCHARGED HOME FROM THE ED AND FOLLOWED UP WITH A SPECIALIST WHO PRESCRIBED HER PHYSICAL THERAPY. NO SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINE. DUE TO THE NEED FOR FOLLOW-UP MEDICAL CARE, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE END-USER EXPERIENCED A FALL AND WAS REQUIRED TO HAVE PHYSICAL THERAPY.