BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3003052 · Received March 13, 2013

    Report

    Report Number
    1531186-2013-01051
    Date Received
    March 13, 2013
    Report Date
    February 14, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR. REPORT # 1531186-2013-01051 INDICTING THE MANUFACTURER AS (B)(4) WITH A SERIAL NUMBER OF (B)(4). THE CORRECT MANUFACTURER IS INVACARE (B)(4) WITH A SERIAL # OF (B)(4). THE CORRECT FDA REGISTRATION # IS (B)(4).

    Description of Event or Problem · 1

    (B)(4) THE DEALER REPORTED THAT THE SPT CUSTOM MECHANICAL WHEELCHAIR ARM SOCKET WELD WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105091 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET SPT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other