BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3578652 · Received January 16, 2014

    Report

    Report Number
    3004493922-2014-00091
    Event Type
    Injury
    Date Received
    January 16, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 10, 2014
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWERED WHEELCHAIR WENT IN REVERSE UNEXPECTEDLY AND THE CARETAKER WAS STUCK BETWEEN THE CHAIR AND WALL. THE CARETAKER SUSTAINED BRUISES, SORENESS IN HIS SHOULDER, AND FELL DUE TO THE EVENT. THE EXTENT OF HIS INJURIES IS UNKNOWN. THE CARETAKER WILL SEEK MEDICAL INTERVENTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42976 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51PSEMIBLUE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention