BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2884492 · Received December 22, 2012

    Report

    Report Number
    9616091-2012-00679
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    December 21, 2012
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER ALLEGES THAT THE SEAT SPLIT ALMOST FRONT TO BACK. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other