BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOROSA

    MDR report key: 3233996 · Received July 18, 2013

    Report

    Report Number
    2125050-2013-00076
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 18, 2013
    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

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST BUT NOT VERIFIED, A SECOND SET OF IMPLANTS EXHIBITED LEAKAGE WAS REPORTED DURING FILLING. PATIENT WAS SUBSEQUENTLY IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333200 TOROSA SALINE FILLED TESTICULAR PROSTHESIS FAF COLOPLAST A/S 5206502400 3557262

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention