BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC(R) TESTICULAR IMPLANT II, LATTIMER DESIGN

    MDR report key: 39222 · Received September 19, 1996

    Report

    Report Number
    1816403-1996-00077
    Event Type
    Injury
    Date Received
    September 19, 1996
    Date of Event
    July 19, 1996
    Report Date
    July 31, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CAME INTO PHYSICIAN'S OFFICE FOR CHECK OF LEFT TESTICULAR PROSTHESIS. FOUND PROSTHESIS TO BE 1/4 (ONE-FOURTH) THE SIZE THAT IT SHOULD HAVE BEEN. SCHEDULED SURGERY AND EXPLANTED PROSTHESIS WITH PROBABLE RUPTURE. POST-OP VISIT, PT OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC(R) TESTICULAR IMPLANT II, LATTIMER DESIGN Implant TESTICULAR IMPLANT, GEL-FILLED FAF DOW CORNING CORP. NA HH105417

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention