BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 4243624 · Received November 11, 2014

    Report

    Report Number
    9616091-2014-02445
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER CONTACTED (B)(6) IN SALES STATING THAT THEIR CUSTOMER'S UPHOLSTERED SEAT IS SAGGING AND RESTING ON THE CROSS BARS. ORIGINAL ORDER (B)(4). DATE OF SALE TO CUSTOMER IS (B)(6) 2014. WITHIN ONE YEAR OF SEAT UPHOLSTERY. NO END USER INFORMATION PROVIDED. (B)(6) IN SALES WILL HAVE DEALER CALL IN FOR WARRANTY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727154 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28RP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other