BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3013810 · Received March 20, 2013

    Report

    Report Number
    9616091-2013-00478
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART NUMBER PROVIDED, 1112182, IS FOR COMMODE MODEL NUMBERS: 9650-4, 9630-4, OR 9630-1 COMMODES. ALL OF THESE ARE MANUFACTURED BY INVAMEX.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER ADVISED THAT THE SEAT WAS STARTING TO CRACK. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115437 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other