BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M MEDIPORE + PAD

    MDR report key: 1677074 · Received May 3, 2010

    Report

    Report Number
    2110898-2010-00043
    Event Type
    Other
    Date Received
    May 3, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 13, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - NO TESTING PERFORMED. RESULTS - PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE HAD BACK SURGERY ON (B)(6) 2010 AND MEDIPORE + PAD WAS APPLIED TO THE INCISION. DRESSING HAD BEEN IN PLACE FOR SEVERAL DAYS AND SHE SAID SHE "BROKE OUT" UNDER THE EDGES OF THE DRESSING. SHE ALLEGES SKIN WAS IRRITATED AND INFLAMED. PHYSICIAN GAVE HER AN ORAL ANTIBIOTIC BECAUSE OF WHAT SHE SAID WAS "A BACTERIAL INFECTION". SHE SAID SHE BEGAN TO BREAK OUT IN HIVES. THE ANTIBIOTIC WAS CHANGED. SHE STATED THAT THE INCISION IS HEALING, BUT STILL HAS HIVES. SHE STATED THAT SHE DOES NOT HAVE HISTORY OF PREVIOUS SKIN REACTION TO ADHESIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M MEDIPORE + PAD SOFT CLOTH ADHESIVE WOUND DRESSING KGX 3M HEALTH CARE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention