BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUODERM EXTRA THIN

    MDR report key: 2108652 · Received May 23, 2011

    Report

    Report Number
    2243969-2011-00015
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 25, 2011
    Manufacturer
    CONVATEC
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON (B)(4) 2011.

    Description of Event or Problem · 1

    THE PT'S MOTHER, A (B)(6) Y/O MALE WAS INVOLVED IN AN ACCIDENT (UNK TYPE) AND HE SUSTAINED A FACIAL FRACTURE (EXTENT UNK), HE WAS HOSPITALIZED ON (B)(6) 2011. NO ADD'L DETAILS ARE KNOWN REGARDING THE COURSE OF THERAPY IN THE HOSP NOR WHETHER OR NOT THE PT UNDERWENT SURGERY. A DUODERM DRESSING WAS USED ON THE FACE JUST BELOW THE EYE AND AFTER 3 DAYS IN HOSP, THE PT WAS DISCHARGED. ONE DAY THEREAFTER, WHAT WAS INITIALLY DESCRIBED AS AN INFLAMMATION WAS NOTICED IN THE AREA WHERE THE DRESSING HAD BEEN PLACED. ALTHOUGH IT IS NOT KNOWN IF THE INFLAMMATION EXTENDED THE ENTIRE SHAPE OF THE DRESSING, IT WAS REPORTED TO HAVE EXTENDED BEYOND THE MARGINS OF THE DRESSING (BELOW IT). ON RESPONSE TO A REQUEST FOR CLARIFYING INFO ABOUT THE NATURE OF THE "INFLAMMATION", IT IS NOW REPORTED TO FIRST HAVE APPEARED AS SWELLING, WHICH THEN BECAME A BLISTER. THE BLISTER IS REPORTED TO HAVE BURST AND CAUSED A DARK PIGMENTATION ON THE PT'S FACE. ALSO, THE PT IS SEEING A PHYSICIAN FOR THIS PROBLEM. THE EVENT IS DEEMED SERIOUS AS THE CUSTOMER CLAIMS PERMANENT IMPAIRMENT OF BODILY STRUCTURE OR FUNCTION (FACIAL SCARRING). A CAUSAL RELATIONSHIP BETWEEN THE DRESSING AND THIS EVENT IS DEEMED POSSIBLY RELATED BECAUSE PRODUCT USE IS TEMPORALLY ASSOCIATED WITH THE SKIN WHERE THE PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUODERM EXTRA THIN WOULD DRESSING MGQ CONVATEC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Disability