BEUDAMED
    FDA Adverse Event Summary report: N

    CRUTCH

    MDR report key: 2883325 · Received December 21, 2012

    Report

    Report Number
    1531186-2012-01836
    Date Received
    December 21, 2012
    Report Date
    December 20, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES COVER KEEPS FALLING DOWN MAKING CRUTCH UNSTABLE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRUTCH 890.3150 IPR UNKNOWN 8115-T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other