BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVERLET ADHESIVE DRESSING -LATEX-FREE-

    MDR report key: 873053 · Received June 25, 2007

    Report

    Report Number
    MW5002830
    Event Type
    Injury
    Date Received
    June 25, 2007
    Date of Event
    June 22, 2007
    Report Date
    June 25, 2007
    Manufacturer
    BSN-JOBST, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I AM WRITING TO COMPLAIN ABOUT COVERLET ADHESIVE DRESSING PRODUCTS - ADHESIVE BANDAGE STRIPS MANUFACTURED BY BSN-JOBST. I HAVE NO KNOWN ALLERGIES, NOR ANY SPECIAL SKIN SENSITIVITIES. YET, ON THE TWO OCCASIONS WHEN I HAVE USED THE PRODUCT, THE ADHESIVE CAUSED AN IRRITATING SKIN RASH, ACTUALLY WORSE THAN THE WOUNDS IT COVERED. I HAVE NEVER EXPERIENCED THIS WITH ANOTHER ADHESIVE BANDAGE, NOR WITH ANY OTHER ADHESIVE IN GENERAL. RECENTLY, I HAD MINOR SURGERY TO REMOVE A PRE-CANCEROUS SKIN LESION ON MY ABDOMEN. I DRESSED THE WOUND WITH A COVERLET AND REPLACED THE DRESSING REGULARLY. THE ITCHY RED MARKS LEFT BY THE ADHESIVE STRIPS LASTED UNTIL WELL AFTER THE SUTURES WERE REMOVED, AND IT TOOK AS LONG FOR THE SKIN AT THE ADHESIVE SITE TO HEAL, AS DID THE PLACE OF INCISION, WEEKS, NOT DAYS. LAST WEEK, I INADVERTENTLY USED ANOTHER COVERLET, TO DRESS A PUNCTURE WOUND ON MY ARM WHERE BLOOD HAD BEEN DRAWN. WHEN I REMOVED THE STRIP, ONCE AGAIN, THERE APPEARED AN ITCHY AND PERSISTENT RED MARK. BSN-JOBST'S COVERLET BOASTS ABOUT BEING LATEX-FREE, YET IT INCORPORATES NO WARNING CONCERNING THE POSSIBILITY OF INJURY FROM OTHER IRRITATING COMPOUNDS. I BELIEVE THAT RELATIVE TO ITS BENIGN APPEARANCE, COVERLETS ARE ONE OF THE MOST HARMFUL PRODUCTS I HAVE EVER ENCOUNTERED. MY SKIN COULD NOT HAVE BEEN MORE IRRITATED IF I HAD DAUBED IT WITH ACID, LYE OR ANOTHER CAUSTIC CHEMICAL. DATES OF USE: TWO DAYS IN 2007, DIAGNOSIS: PUNCTURE DRESSING, EVENT ABATED USE STOPPED: YES. EVENT REAPPEARED: YES. DATES OF USE: FOURTEEN DAYS IN 2006. DIAGNOSIS: SURGICAL DRESSING. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVERLET ADHESIVE DRESSING -LATEX-FREE- "BANDAID" TYPE STRIP KGX BSN-JOBST, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other