BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMOENA

    MDR report key: 172329 · Received June 13, 1998

    Report

    Report Number
    1046831-1998-00001
    Event Type
    Injury
    Date Received
    June 13, 1998
    Date of Event
    July 15, 1997
    Report Date
    June 2, 1998
    Manufacturer
    COLOPLAST CORP
    Product Code
    KCZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SEAM OF THE EXTERNAL BREAST PROSTHESIS RUPTURED CAUSING SILICONE TO COME IN CONTACT WITH THE SKIN ON PT'S CHEST WALL. PT CLAIMS CHEST TURNED RED AS A RESULT OF A CHEMICAL BURN. PT WAS TAKEN TO THE HOSP FOR BACK SURGERY DUE TO HERNIATED LUMBAR DISK. WHILE PREPARING FOR SURGERY, DR NOTED PAIN, REDNESS AND SWELLING OF THE RIGHT ARM OF THE PT AND DIAGNOSED BACTERIAL CELLULITIS, ALLEGEDLY CAUSED BY THE BREAST PROSTHESIS RUPTURING. THE PT WAS GIVEN AN ANTIBIOTIC (ANCEF 2.0 GRAMS INTRAVENOUSLY EVERY EIGHT HOURS) AND THE BACTERIAL CELLULITIS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMOENA EXTERNAL BREAST PROSTHESIS KCZ COLOPLAST CORP 802 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R