BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE TESTICULAR, MEDIUM

    MDR report key: 500478 · Received December 11, 2003

    Report

    Report Number
    2125050-2003-00537
    Event Type
    Injury
    Date Received
    December 11, 2003
    Date of Event
    December 2, 2003
    Report Date
    December 5, 2003
    Manufacturer
    MENTOR CORPORATION - MINNESOTA DIVISI
    Product Code
    FAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION THERE WAS EXTRUSION OF THE DEVICE THROUGH THE SCROTUM. ALSO ABSENCE OF FLUID WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE TESTICULAR, MEDIUM TESTICULAR PRODUCTS FAF MENTOR CORPORATION - MINNESOTA DIVISI 450-1327 796773

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R