BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMSCO MEDALLION GP

    MDR report key: 10312 · Received August 16, 1993

    Report

    Report Number
    10312
    Event Type
    Injury
    Date Received
    August 16, 1993
    Date of Event
    July 15, 1993
    Report Date
    August 9, 1993
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED INFECTION DUE TO INADEQUATE STERILIZATION OF SURGICAL INSTRUMENTS. INSTRUMENTS WERE STERILIZED IN STERILIZER. DURING BILOGICAL TESTING PERFORMED DAILY, IT WAS DISCOVERED THAT STERILIZATION WAS NOT EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMSCO MEDALLION GP STERILIZER FLE AMERICAN STERILIZER CO. MEDALLION GP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention VACUUM EXTRACTOR, DEBACLES