BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M CAVILON NO STING BARRIER SPRAY

    MDR report key: 2465606 · Received February 16, 2012

    Report

    Report Number
    MW5024300
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    November 16, 2011
    Report Date
    February 16, 2012
    Manufacturer
    3M HEALTH CARE LTD.
    Product Code
    KOY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT CAME TO THE DERMATOLOGY DEPT DUE TO PERSISTENT SEVERE PERISTOMAL DERMATITIS. SHE BROUGHT WITH HER THE PRODUCTS SHE USED FOR HER ILEOSTOMY SITE. SHE WAS FOUND TO HAVE A SEVERE BLISTERING REACTION TO 3M CAVILON NO-STING BARRIER SPRAY WHEN PATCH TESTED TO HER PRODUCTS, THE NO STING BARRIER SPRAY IS USED TO "PROTECT" THE AREA. WE CONTACTED 3M WHO SAID THEY HAVE HAD REPORTS OF SIMILAR REACTIONS FROM THIS PRODUCT, BUT WHEN SEARCHING MAUDE, NO OTHER HAVE BEEN REPORTED TO THE FDA. 3M DECLINED TO SEND THE INDIVIDUAL INGREDIENTS IN THERE CAVILON NO-STING BARRIER SPRAY TO DETERMINE WHAT WITHIN THE PRODUCT WAS CAUSING THE PT TO HAVE THE BULLOUS REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M CAVILON NO STING BARRIER SPRAY 3M CAVILON NO STING BARRIER SPRAY, 28 ML KOY 3M HEALTH CARE LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other