BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 3140923 · Received June 3, 2013

    Report

    Report Number
    1525712-2013-04284
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    INVAMEX
    Product Code
    KNN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE (B)(6) 2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). LEG RESTS, PART NUMBER 8881091764, MANUFACTURED BY IVC INVAMEX. CORRECTION OF DEVICE AND KNOWN MANUFACTURER.

    Description of Event or Problem · 1

    PER PROVIDER BROKEN LEG REST PADS.

    Description of Event or Problem · 1

    PER PROVIDER, BROKEN LEG REST PADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244912 WHEELCHAIR COMPONENTS 890.3920 KNN INVAMEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other