BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABTOX 155

    MDR report key: 177171 · Received July 8, 1998

    Report

    Report Number
    MW1014169
    Event Type
    Injury
    Date Received
    July 8, 1998
    Date of Event
    October 6, 1995
    Report Date
    July 6, 1998
    Manufacturer
    ABTOX, INC.
    Product Code
    MLR
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RPTR WANTS TO KNOW WHY DEVICE WAS RECALLED BY MFG AND FOOD AND DRUG ADMINISTRATION. RPTR CONTRACTED ACTINOMYCOSIS, (FUNGI) WHICH CAN ONLY BE CAUGHT FROM CATTLE, HOGS, AND SHEEP; OR UNSTERILE INSTRUMENTS. "I LOST MY EYE." RPTR WOULD LIKE TO KNOW THE PARTICULARS ON THIS MACHINE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABTOX 155 PLAZLYTE STERILIZATION SYSTEM MLR ABTOX, INC. 155 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R| S