BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDIAN FOREARM CRUTCH

    MDR report key: 1844070 · Received September 2, 2010

    Report

    Report Number
    3006459587-2010-00006
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    March 28, 2010
    Report Date
    August 6, 2010
    Manufacturer
    PROFIT COUNTRY ENTERPRISES LTD
    Product Code
    IPR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE CUFF CRUTCH THE STAFF BROKE AND THE EU WAS INJURED REQUIRING STITCHES AT THE EMERGENCY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDIAN FOREARM CRUTCH CUFF CRUTCH IPR PROFIT COUNTRY ENTERPRISES LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention