BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLEEK TAPE

    MDR report key: 170985 · Received June 2, 1998

    Report

    Report Number
    1017593-1998-00002
    Event Type
    Other
    Date Received
    June 2, 1998
    Date of Event
    April 18, 1998
    Report Date
    June 1, 1998
    Manufacturer
    SMITH & NEPHEW, INC./WOUND MANAGEMENT DIVISION
    Product Code
    KGX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SMITH & NEPHEW WOUND MANAGEMENT DIVISION WAS CONTACTED BY HY-TAPE SURGICAL PRODUCTS CORPORATION REGARDING A COMPLAINT ON SLEEK TAPE. SLEEK TAPE IS A BULK ROLL TAPE PRODUCT MFG BY SMITH & NEPHEW MEDICAL IN ENGLAND AND DISTRIBUTED BY SMITH & NEPHEW WOUND MANAGEMENT DIVISION OF HY-TAPE SURGICAL PRODUCTS CORP. HY-TAPE REPROCESSES THESE ROLLS INTO SMALL TAPE ROLLS AND PACKAGES IN HY-TAPE PACKAGING CONFIGURATIONS. SMITH & NEPHEW IS NEVERTHELESS SUBMITTING THIS REPORT BASED ON THE INFO REC'D FROM HY-TAPE. THE COMPLAINT INFO FROM HY-TAPE INDICATED THAT THEY REC'D INFO FROM THE HOSPITAL IS THAT TAPE WAS BEING USED ON A 25 WEEK PREMATURE INFANT TO SECURE AN ENDOTRACHEAL TUBE. WHEN THE TAPE WAS REMOVED, THERE WAS A SEVERE SKIN AFFLICTION ON THE PT'S SKIN. SUTURES WERE NECESSARY AT THE TIME OF THE INCIDENT AND F/U HAS INDICATED THE AREA IS HEALING. ONE (1) RETURN SAMPLE WAS PROVIDED TO SMITH & NEPHEW FOR THE INVESTIGATION. THE RESULTS INDICATED THAT THE APPEARANCE AND SUBJECTIVE PROPERTIES WERE CONSIDERED TO BE SATISFACTORY WITH NO UNUSUAL PROBLEMS NOTED WITH THE RETURNED SAMPLE. THE REMOVAL TECHNIQUE OF HY-TAPE (SLEEK TAPE) MAY BE RELEVANT IN THAT THE AMOUNT OF FORCE USED COULD AGGRAVATE SKIN STRIPPING. PT'S WEIGHT: 1.8 OUNCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLEEK TAPE TAPE, ADHESIVE BANDAGE KGX SMITH & NEPHEW, INC./WOUND MANAGEMENT DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5 MO Required Intervention