BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL DRAPE

    MDR report key: 868643 · Received June 20, 2007

    Report

    Report Number
    8044184-2007-00079
    Event Type
    Other
    Date Received
    June 20, 2007
    Date of Event
    May 17, 2007
    Report Date
    June 20, 2007
    Manufacturer
    KIMBERLY CLARK CORP
    Product Code
    KKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE COMPLAINT DEALT WITH THE TAPE TO THE DRAPE WHICH IS PROCURED FROM 3M, THEY WERE CONTACTED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    ON 5/17/07, A REPORT WAS RECEIVED THAT PT HAD A 4MM ROUND AREA ON THE UPPER ARM WHERE THE SKIN WAS REMOVED AFTER UNDERGOING OPEN HEART SURGERY THAT LASTED 3 HRS. NURSE STATED THAT WHEN THE DRAPE WAS REMOVED THE SKIN CAME OFF WHERE THE ADHESIVE TOUCHED THE ARM. THE NURSE NOTED THE CHILD HAS SENSITIVE SKIN BECAUSE THE IOBAN PREP THAT WAS USED REMOVED A LIGHT LAYER OF SKIN ON THE CHILD'S CHEST. DEBRIDEMENT OF THE WOUND WAS DONE BY PLASTIC SURGEON DR. WHO APPLIED SILVADINE AND A MESH WRAP WITH GAUZE TO THE UPPER ARM. HE CLASSIFIED THE WOUND AS A 2ND DEGREE BURN. KIMBERLY-CLARK HAS NO FIRST HAND KNOWLEDGE OF THE ALLEGATIONS, BUT IS RELAYING THE INFO RECEIVED FROM OUTSIDE SOURCES PURSUANT TO FEDERAL REG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL DRAPE SURGICAL DRAPE KKX KIMBERLY CLARK CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other