BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WEIGHTRIGHT MERCURY-FREE

    MDR report key: 5103678 · Received September 25, 2015

    Report

    Report Number
    5103678
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 18, 2015
    Manufacturer
    MEDOVATIONS INC.
    Product Code
    FAT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE NURSE AND TECH WENT TO THE SHELF THEY NOTICED THE BOUGIE TUBES HAD A LOT NUMBER AND DATE THAT SEEMED TO BE PUT ON THE TUBES WITH A MARKER INSTEAD OF BEING STAMPED ON. HARD TO TELL. ITEMS WERE EXPIRING AND REP TOLD THE OPERATING ROOM STAFF NOT TO USE THEM SINCE THEY WERE EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634416 WEIGHTRIGHT MERCURY-FREE BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY FAT MEDOVATIONS INC. 1208-52 213676

    Patients

    Seq Age Sex Outcome Treatment
    1