BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEROSA

    MDR report key: 3899182 · Received May 12, 2014

    Report

    Report Number
    2125050-2014-00367
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 12, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAF
    PMA / PMN Number
    P020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    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 THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH TOROSA SALINE TESTICULAR (LARGE). LATER THE PATIENT EXPERIENCED AN EXPLANT OF THE DEVICE DUE TO DEVICE DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284447 TEROSA SALINE FILLED TESTICULAR PROSTHESIS, PRODUCT CODE: FAF FAF COLOPLAST A/S 5206502400 3660019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other