BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN

    MDR report key: 5398049 · Received January 22, 2016

    Report

    Report Number
    MW5059764
    Event Type
    Injury
    Date Received
    January 22, 2016
    Date of Event
    January 20, 2016
    Report Date
    January 22, 2016
    Manufacturer
    MEDLINE INC
    Product Code
    INP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS RECENTLY PRESCRIBED FOREARM CRUTCHES AND THE VENDOR ISSUED THE MEDLINE "GUARDIAN" BRAND FOREARM CRUTCHES. THE WEIGHT LIMITATIONS ARE SUPPOSED TO BE UP TO (B)(6) SUPPORT AND I WEIGHT ABOUT (B)(6). WHILE USING THE CRUTCHES TO GO FROM MY LIVING ROOM TO MY KITCHEN, THE CRUTCH ON MY LEFT ARM SNAPPED (THERE IS A PLASTIC ADJUSTMENT BAR THAT SLIDES INTO A METAL CRUTCH) RESULTING IN ME FALLING ONTO THE CRUTCH THAT FELL BEHIND ME AS IT BROKE WHERE MY RIGHT HIP AND UPPER SPINE HIT NOT ONLY THE CRUTCH, BUT THE FLOOR AS WELL WHEN I FELL. I THEN HAD TO CRAWL INTO THE NEXT ROOM AND BE TAKEN BY AMBULANCE TO THE HOSPITAL. I HAVE HAD TO HAVE ASSISTANCE WITH ALL ACTIVITIES SINCE AND WAITING FOR FURTHER TESTING FROM MY PRIMARY CARE PHYSICIAN TO DETERMINE EXTENT OF INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45321 GUARDIAN GUARDIAN INP MEDLINE INC G05161 40315050025

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| O| S NAPROXEN 500MGS