BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3011795 · Received March 19, 2013

    Report

    Report Number
    1531186-2013-01137
    Date Received
    March 19, 2013
    Report Date
    February 25, 2013
    Manufacturer
    JUMAO MEDICAL EQUIPMENT
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVACARE CONTACTED END USERS WIFE, THE WIFE STATED THAT HER HUSBAND HAD FALLEN OUT OF HIS VERANDA (B)(4) MANUAL WHEELCHAIR SEVERAL TIMES SUSTAINING BRUISING. NO MEDICAL INTERVENTION ALLEGED. THE END USER IS A BELOW THE KNEE AMPUTEE. WHEN USER ATTEMPTED TO TRANSFER FROM THE CHAIR THE WHEEL LOCKS WOULD GIVE WAY CAUSING THE CHAIR TO ROLL OUT FROM BEHIND HIM, CAUSING THE USER TO FALL FROM THE CHAIR. THE CONSUMER TOOK THE CHAIR TO THE DEALER WHO ADVISED THEM THAT THE WHEELS ON THE CHAIR ARE NON INVACARE AND THAT IS WHY THE WHEEL LOCKS ARE NOT HOLDING. THE USER OBTAINED THIS WHEELCHAIR FROM A REHAB FACILITY, NOT REALIZING THAT THE WRONG WHEELS WERE ON THE PRODUCT. RETURN MATERIAL AUTHORIZATION (B)(4) HAS BEEN ISSUED FOR THIS INCIDENT. THE PRODUCT IS TO BE RETURNED TO INVACARE FOR AN EVALUATION.

    Description of Event or Problem · 1

    WHEEL LOCKS ON A (B)(4) MANUAL WHEELCHAIR ARE NOT HOLDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113438 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JUMAO MEDICAL EQUIPMENT V18RFR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 MO Other