BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3056545 · Received April 12, 2013

    Report

    Report Number
    9616091-2013-00615
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    March 18, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM NUMBER PROVIDED, 1112182, IS LINKED TO MODEL NUMBERS MODEL 9650-4, 9630-4, 9630-1, ALL MANUFACTURED BY INVAMEX.

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR. REPORT # 9616091-2013-00615 INDICATING THE MANUFACTURER AS UNKNOWN. THE CORRECT MANUFACTURER IS INVAMEX.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES TOILET SEAT HAS CRACKED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159290 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other