BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1080887 · Received July 24, 2008

    Report

    Report Number
    2084725-2008-00408
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: SKIN CONTACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PT WHO EXPERIENCED A REACTION AFTER AN EXAMINATION WITH AN OLYMPUS SCOPE THAT HAD BEEN PROCESSED IN AN AER USING CIDEX OPA. IT WAS REPORTED THAT THE PT EXPERIENCED A HIGH FEVER, CHILLS, AND BLOODY DIARRHEA. THE PT WAS TREATED WITH AN UNK ANTIBIOTIC AND AN UNK STEROID AND RECOVERED WITHOUT FURTHER ISSUE. WAITING FOR THE CUSTOMER TO RECEIVE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CATALOG #20390| LOT # UNK| CIDEX OPA