BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE-FILLED TESTICULAR PROSTHESIS

    MDR report key: 1153226 · Received September 4, 2008

    Report

    Report Number
    2125050-2008-00005
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    July 11, 2008
    Report Date
    August 7, 2008
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FAF
    PMA / PMN Number
    P020003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST WAS UNSUCCESSFUL IN SECURING THE EXPLANTED PROSTHESIS FOR EVAL, AS THE INITIAL REPORTER STATED THE DEVICE WOULD NOT BE RETURNED. HOWEVER, BECAUSE QA'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF INFECTION, COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. A REVIEW OF THE LOT HISTORY RECORDS INDICATES THIS LOT PASSED STERILITY TESTING PRIOR TO BEING RELEASED. BASED ON THIS KNOWLEDGE, IT IS CONCLUDED THAT THE DEVICE WAS STERILE PRIOR TO THE DEVICE PACKAGING BEING OPENED AND THAT THE INFECTION ORIGINATED FROM SOURCE(S) OTHER THAN DEVICE.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THE TESTICULAR IMPLANT BECAME INFECTED, WITH PURULENT MATERIAL NOTED IN THE DEPENDENT PORTION OF THE PROSTHESIS. IMPLANT WAS REMOVED AND PT WAS DISCHARGED WITH ANTIBIOTICS. CULTURE RESULTS WERE POSITIVE FOR STAPH AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE-FILLED TESTICULAR PROSTHESIS TESTICULAR PROSTHESIS FAF COLOPLAST MANUFACTURING US, LLC 450-1329-E 5710062

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention