BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3950681 · Received July 22, 2014

    Report

    Report Number
    9616091-2014-01258
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE END USER WAS REACHING BEHIND HIM IN HIS 9TPZ WHEELCHAIR, TO POSITION A PILLOW, AND CUT HIS ARM ON A ROUGH AREA ON CHAIR. USER SUSTAINED A SKINTEAR TO THE RIGHT ARM, BRUISED AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428769 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9TPZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other