BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSA W/LEC, PS80

    MDR report key: 6587330 · Received May 22, 2017

    Report

    Report Number
    MW5069998
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 22, 2017
    Manufacturer
    THERMO FISHER SCIENTIFIC
    Product Code
    LIB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    UPON OPENING BOX OF CONTACT PLATES, TECHNICIAN DISCOVERED CONTAMINATED REMEL TSA W/LEC, PS80 CONTACT PLATE WITH GROWTH (REF: 111101, LOT # 139212, EXP. 08/03/2017). A SECOND CONTAMINATED PLATE WITH SAME LOT # DISCOVERED DURING CALL WITH REMEL TECHNICAL SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361995 TSA W/LEC, PS80 TSA W/LEC, PS80 LIB THERMO FISHER SCIENTIFIC 139212
    361996 TSA W/LEC, PS80 TSA W/LEC, PS80 LIB THERMO FISHER SCIENTIFIC 139212

    Patients

    Seq Age Sex Outcome Treatment
    1