BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 HOUR STEAM BIOLOGIC

    MDR report key: 507275 · Received January 7, 2004

    Report

    Report Number
    MW1030827
    Event Type
    Malfunction
    Date Received
    January 7, 2004
    Manufacturer
    3M
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE AUTOREADER SHOWED POSITIVE BIOLOGICAL. UPON OBSERVATION THE BIOLOGICAL DID NOT CHANGE COLOR, WHICH WOULD INDICATE THAT THIS WAS A FALSE POSITIVE. THIS WAS THE SECOND OCCURRENCE IN THE LAST MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 HOUR STEAM BIOLOGIC BIOLOGIC JOJ 3M PRODUCT #1292 2005-10-DE

    Patients

    Seq Age Sex Outcome Treatment
    1 *