BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOROSA

    MDR report key: 2822180 · Received April 30, 2012

    Report

    Report Number
    2125050-2012-00022
    Event Type
    Injury
    Date Received
    April 30, 2012
    Date of Event
    April 3, 2012
    Report Date
    April 30, 2012
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAF
    PMA / PMN Number
    P020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TESTICULAR DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE RETURNED COMPONENT REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORT OF EROSION. COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THE PRODUCT LITERATURE THAT ACCOMPANIES THIS DEVICE ADDRESSES THE POTENTIAL POST OPERATIVE COMPLICATIONS SUCH AS THIS.

    Description of Event or Problem · 1

    DEVICE ERODED THROUGH THE SCROTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOROSA SALINE FILED TESTICULAR PROSTHESIS FAF COLOPLAST A/S 5206302400 3000205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention