BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3020157 · Received March 25, 2013

    Report

    Report Number
    9616091-2013-00501
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    INVAMEX
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATED THE SEAT ON 2 UNITS ARE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121546 DAILY ACTIVITY ASSIST DEVICES 890.5050 ILS INVAMEX 1-0110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other