BEUDAMED
    FDA Adverse Event Other Summary report: N

    REM POLYHESIVE II

    MDR report key: 17165 · Received August 30, 1994

    Report

    Report Number
    17165
    Event Type
    Other
    Date Received
    August 30, 1994
    Date of Event
    August 24, 1994
    Report Date
    August 30, 1994
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AT END OF PROCEDURE, PROCTOSIGMOIDOSCOPY AND VAGINOSCOPY, A 1 CM BURN ON RIGHT ANTERIOR THIGH WAS NOTICED AT THE SITE OF THE GROUND PAD. PT WAS IN LITHOTOMY POSITION. GROUND PAD NOTICED TO HAVE SMALL HOLE IN CORNER OF ADHESIVE BORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REM POLYHESIVE II ESU GROUND PAD GEI VALLEYLAB, INC. 200111

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other