BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOROSA

    MDR report key: 2564654 · Received May 8, 2012

    Report

    Report Number
    2125050-2012-00023
    Event Type
    Injury
    Date Received
    May 8, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 10, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAF
    PMA / PMN Number
    P020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED COMPONENTS REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORT OF EROSION. IT WAS REPORTED THAT THE UROLOGIST DID IMPLANTED THE LARGE SIZE AND ASSUMED THE SCROTUM WOULD EXPAND TO THEM. BASED ON THIS INFORMATION NO CONCLUSIONS CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    BOTH TESTICULAR DEVICES ERODING LATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOROSA SALINE FILLED TESTICULAR PROSTHESIS FAF COLOPLAST A/S 5206502400 2679556

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention