BEUDAMED
    FDA Adverse Event Other Summary report: N

    AER MODEL 387

    MDR report key: 569690 · Received February 1, 2005

    Report

    Report Number
    2084725-2005-00025
    Event Type
    Other
    Date Received
    February 1, 2005
    Date of Event
    September 8, 2004
    Report Date
    September 9, 2004
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PT EXPERIENCED BLOODY DIARRHEA AND CRAMPING 1 DAY POST COLONOSCOPY PROCEDURE. STATES THE SYMPTOMS WERE FROM A SCOPE THAT WAS NOT RINSED PROPERLY. THE SCOPE WAS PROCESSED IN AN AUTOMATED ENDOSCOPE RE-PROCESSOR. THE PT WAS TREATED WITH VICODAN AND BENTYL AND UNDERWENT A FLEXIBLE SIGMOIDOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AER MODEL 387 AUTOMATIC ENDOSCOPE KOG ADVANCED STERILIZATION PRODUCTS 20301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other