BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMEL SABOURAUD DEXTROSE CONTACT PLATE

    MDR report key: 6776817 · Received August 7, 2017

    Report

    Report Number
    MW5071455
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 7, 2017
    Manufacturer
    REMEL THERMO FISHER SCIENTIFIC
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN OPENED BOX OF REMEL SAB DEX CONTACT PLATES (PRODUCT #R111105, LOT #177380, EXP #09/21/2017) TO FIND ONE CONTAMINATED WITH PROFUSE BLACK GROWTH. REPORTED TO THERMO FISHER SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553087 REMEL SABOURAUD DEXTROSE CONTACT PLATE SABOURAUD DEXTROSE CONTACT PLATE JSG REMEL THERMO FISHER SCIENTIFIC 177380

    Patients

    Seq Age Sex Outcome Treatment
    1