BEUDAMED
    FDA Adverse Event Summary report: N

    TAPE WATERPROOF 1IN

    MDR report key: 2073152 · Received April 29, 2011

    Report

    Report Number
    1423537-2011-00022
    Date Received
    April 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    April 29, 2011
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED AND EVALUATED. THE TAPE IS MADE WITH ACRYLIC ADHESIVE AND COTTON FABRIC COATING WITH POLYETHYLENE AND PASSED BIOLOGICAL COMPATIBILITY TESTING FOR THE ADHESIVE PRIOR TO PRODUCTION. THIS PRODUCT WAS FIRST MANUFACTURED IN 2009 FOR CARDINAL HEALTH WITH ONLY 4 LOT NUMBERS, 0910-SH, 1003-SH, 1006-SH AND 1009-SH. THE DHR WAS REVIEWED AND NO PROBLEMS IN MANUFACTURING OR ABNORMALITIES WERE FOUND. THERE HAVE BEEN NO CHANGES IN THE MATERIALS OR METHODS USED TO MANUFACTURE THIS WATERPROOF TAPE. THE REPORT IS STILL UNDER INVESTIGATION. AS APPLICABLE, A CORRECTIVE AND PREVENTIVE ACTION WILL BE INITIATED ONCE THE POTENTIAL CAUSE IS IDENTIFIED.

    Description of Event or Problem · 1

    OVER A TWO WEEK SPAN, STARTING (B)(6) 2011, (B)(6) WAS GETTING PAGED BY ICU AND RESPIRATORY OFTEN IN REGARDS TO SKIN REACTIONS THEY WERE SEEING WITH ANY OF THE ENDOTRACH TUBES THAT WERE ATTACHED UTILIZING THE (B)(4). THE REACTIONS WOULD BEGIN 24 HR POST AND THE REACTIONS WOULD START WITH BLISTERS AND THEN WOULD EXACERBATE WITH SKIN BREAKDOWN. PLEASE NOTE EACH PT. W/AN ENDOTRACH TUBE HAS MASTISOL GLUE APPLIED PRIOR TO THE TAPE AND SOMETIMES THE 3M CAVALON NO STING BARRIER FILM IS ADDED. SINCE STOPPING THE USE OF THE CARDINAL PRODUCT AND GOING BACK TO KIMBERLY CLARK THEY IMMEDIATELY STOPPED SEEING THE SKIN REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAPE WATERPROOF 1IN TAPE WATERPROOF 1IN KGX CAHWPT1 NO LOT GIVEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other