BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN SELECT CRUTCHES

    MDR report key: 2213262 · Received August 10, 2011

    Report

    Report Number
    MW5021728
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    June 18, 2010
    Report Date
    August 10, 2011
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    INP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS WALKING WITH MY GUARDIAN SELECT CRUTCHES MODEL NUMBER G-92-214-8 AND THE TOP OF THE CRUTCH CAME OFF CAUSING MY RIGHT ARM TO LUNGE OUT TO THE SIDE WITH EXCESSIVE FORCE BECAUSE, I HAD FULL WEIGHT BEARING ON THE RIGHT BECAUSE, I HAD ANKLE SURGERY ON MY LEFT AND COULD NOT PUT ANY PRESSURE ON THE LEFT ANKLE AT ALL. THE INJURIES I SUSTAINED WAS A BROKEN ARM AND SURGERY TO REPAIR THE LABRUM AND RE-ATTACH THE TENDON. I HAVE BEEN IN PHYSICAL THERAPY FOR OVER A YEAR NOW. THE TOP OF THE CRUTCH APPEARS AS IF IT IS JUST HELD ON BY THE PRESSURE OF THE METAL BECAUSE, THERE ARE NO RIVITS OR BOLTS TO HOLD THE TOP ON. DATES OF USE: (B)(6) 2010. REASON FOR USE: LEFT ANKLE TENDON REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN SELECT CRUTCHES CRUTCHES YOUTH/ADOLESCENT/JUVENI INP SUNRISE MEDICAL G92-214-8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention