BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE TESTICULAR

    MDR report key: 537409 · Received March 23, 2004

    Report

    Report Number
    2125050-2004-00126
    Event Type
    Injury
    Date Received
    March 23, 2004
    Date of Event
    March 5, 2004
    Manufacturer
    MENTOR CORPORATION - MINNESOTA DIVISON
    Product Code
    FAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION THE PT HEARD A "POP" WITH PROSTHESIS AND FELT SALINE LEAK OUT OF DEVICE INTO SCROTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE TESTICULAR TESTICULAR DEVICE FAF MENTOR CORPORATION - MINNESOTA DIVISON NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R