inforMED
MalfunctionINP

ENDURANCE FOREARM CRUTCH

Received Mar 18, 2014

Report 1056127-2014-00004 · MDR key 3713735

Device

Generic name

Forearm Crutch

Model number

ST601A

Catalog number

W4102

Product problems

  • Detachment Of Device Component

Patient

31 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

PT TOLD DEALER THAT HE HAD NOTICED THAT A CUFF ON ONE OF THE PAIR OF HIS FOREARM CRUTCHES WAS LOOSE AND HE CONTINUED TO USE IT UNTIL IT SEPARATED COMPLETELY. WHEN THE CRUTCHES WERE RETURNED TO THE DEALER ONE OF THE PAIR DID SHOW THE SEPARATION. THERE WAS NO SIMILAR PROBLEM WITH THE SECOND.