BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUKAL CORPORATION

    MDR report key: 1604061 · Received February 7, 2010

    Report

    Report Number
    MW5014744
    Event Type
    Injury
    Date Received
    February 7, 2010
    Date of Event
    January 30, 2010
    Report Date
    January 30, 2010
    Manufacturer
    DUKAL CORPORATION
    Product Code
    FQM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD A SKIN CANCER REMOVED FROM MY RIGHT RIB AREA. THE DERMATOLOGIST COVERED THE WOUND WITH A (B) (4) BRAND BANDAGE AND THE WOUND STARTED TO HEAL. I USED A DIFFERENT BRAND OF BANDAGE, DUKAL CORP ADHESIVE BANDAGE (7602), NINE DAYS LATER. TWENTY FOUR HOURS LATER, THERE WERE LARGE WELTS ON MY SKIN WHERE THE ADHESIVE PART OF THE BANDAGE CONTACTED MY SKIN. I HAVE A PICTURE OF THE WELTS FOR PROOF OF THE PROBLEM AND CAN EMAIL THEM IF NECESSARY. DOSE OR AMOUNT: NA. DATES OF USE: ONE TIME: (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: WOUND PROTECTION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUKAL CORPORATION STERILE KNUCKLE ADHESIVE BANDAGE FQM DUKAL CORPORATION 7602 C24808

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR