BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREEZY ULTRA 4

    MDR report key: 2111820 · Received November 4, 2008

    Report

    Report Number
    3006459587-2008-00074
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 17, 2008
    Report Date
    October 29, 2008
    Manufacturer
    SUNRISE MEDICAL
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BACK CANE OF THE WHEEL CHAIR BROKE AT ONE OF THE HOLES USED TO ADJUST THE CANE HEIGHT. NO DEFORMATION OF THE HOLES WAS EVIDENT. APPEARS THIS CANE BROKE WITH NO CAUSE. CANES LOOK IN GOOD SHAPE AND DOES NOT APPEAR TO BE ABUSED.

    Description of Event or Problem · 1

    BACK CANE OF WHEEL CHAIR BROKE DURING USE. THE USER FELL BACKWARDS. THE USER HAD A SORE SHOULDER RESULTING FROM THE INCIDENT BUT DID NOT RECEIVE MEDICAL ATTENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other