BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZY ULTRA 4 WHEELCHAIR

    MDR report key: 1052397 · Received May 22, 2008

    Report

    Report Number
    3006459587-2008-00013
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 17, 2008
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THESE DEVICES WILL BE RETURNED TO THE MFR FOR EVAL UNDER INDIVIDUAL RMA NUMBERS.

    Description of Event or Problem · 1

    WE WERE NOTIFIED THROUGH A MEDWATCH REPORT THAT THERE WERE INCIDENTS WHERE THE BACK CANE OF THE WHEELCHAIR HAD BROKEN. CHAIRS ARE BEING RETURNED FOR EVAL UNDER INDIVIDUAL RMA NUMBERS FOR TRACEABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREEZY ULTRA 4 WHEELCHAIR WHEELCHAIR IOR SUNRISE MEDICAL EIB7-K4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other