BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HY-TAPE

    MDR report key: 8186218 · Received December 19, 2018

    Report

    Report Number
    MW5082358
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    December 15, 2018
    Report Date
    December 18, 2018
    Manufacturer
    HY-TAPE INTERNATIONAL, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I DEVELOPED CONTACT DERMATITIS FROM 2 DIFFERENT ADHESIVE PRODUCTS USED IN THE OPERATING ROOM DURING SURGERY. ONE WAS A TAPE (HY-TAPE) USED TO HOLD THE ET TUBE IN PLACE. I GOT A RASH ACROSS MY WHOLE FACE BELOW THE NOSE. THE OTHER WAS FROM A MONITOR LEAD. CLEAR TRACE, USED TO DEFECT NERVE/MUSCLE FASCICULATIONS DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022335 HY-TAPE TAPE AND BANDAGE, ADHESIVE KGX HY-TAPE INTERNATIONAL, INC.
    1022345 CLEAR TRACE ELECTRODES ELECTRODE, ELECTROSURGICAL JOS CONMED CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| S