BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2880950 · Received December 20, 2012

    Report

    Report Number
    1531186-2012-01811
    Date Received
    December 20, 2012
    Report Date
    December 19, 2012
    Manufacturer
    GENTEEL HOMECARE PRODUCTS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER STATED THE LEFT BRAKE SNAPPED AND THIS IS THE SECOND TIME HE HAS HAD TO REPLACE THE BRAKES ON THE WALKER. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 ITJ GENTEEL HOMECARE PRODUCTS 65100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other