BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE MANUAL WHEELCHAIR

    MDR report key: 506782 · Received January 9, 2004

    Report

    Report Number
    1525712-2004-00007
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    September 1, 2003
    Manufacturer
    CUSTOM MANUAL.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER HAS HAD 2 INCIDENTS REGARDING THIS MVP CHAIR. THE FIRST IN 9/03 ALLEGEDLY RESULTED IN A 4" CUT REQUIRING BUTTERFLY TAPE, WHEN THE BOLT FROM THE RIGHT FORK AND STEM ALLEGEDY SNAPPED. THE SECOND INCIDENT WAS 12/2003 WHEN THE RIGHT FRAME, WHERE THE BACK CANE ATTACHES TO THE REST OF THE FRAME, ALLEGEDLY BROKE. NO INJURY ALLEGED AS A RESULT OF THE LAST INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE MANUAL WHEELCHAIR 890.3850 IOR CUSTOM MANUAL. ACTIONMVP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention