BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3000227 · Received March 12, 2013

    Report

    Report Number
    9616091-2013-00426
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CONSUMER STATES TOP LID ON COMMODE IS SPLIT ON BOTH SIDES. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103171 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other