BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 4191673 · Received October 22, 2014

    Report

    Report Number
    9616091-2014-02212
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Report Date
    September 30, 2014
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    (B)(4): PER END USER'S HUSBAND, THE SEAT WAS PINCHING WIFE'S LEGS WHEN SHE USED THE DEVICE, SO THEY BOUGHT A NEW SEAT. NO BRUISING/BROKEN SKIN. (B)(4): GRANDDAUGHTER STEPPED ON SEAT TO GET SOMETHING OUT OF A CABINET AND CRACKED THE SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674239 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 9630-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other