BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3711448 · Received March 31, 2014

    Report

    Report Number
    9616091-2014-00555
    Event Type
    Malfunction
    Date Received
    March 31, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 28, 2014
    Manufacturer
    INVAMEX
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PROVIDER STATED SEAT IS CRACKED THEY CANNOT LOCATE LOT NUMBER. PN 1112198.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191415 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX INVAMEX 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other