BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPAZ 22X20 EXPORT UK

    MDR report key: 4811602 · Received June 2, 2015

    Report

    Report Number
    9616091-2015-01374
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 4, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD MORE PERTINENT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE BOLT HAS BROKE ON THE RIGHT REAR SIDE OF THE CROSSBRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356752 TOPAZ 22X20 EXPORT UK WHEELCHAIR, MECHANICAL IOR INVAMEX 9TPZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other