BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2912472 · Received January 12, 2013

    Report

    Report Number
    9616091-2013-00059
    Event Type
    Malfunction
    Date Received
    January 12, 2013
    Report Date
    January 12, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER STATES THE SEAT CRACKED FROM BACK OF SEAT TO THE TOP. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19419 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other