BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY IMPLANT

    MDR report key: 45092 · Received October 23, 1996

    Report

    Report Number
    1816403-1996-00188
    Event Type
    Injury
    Date Received
    October 23, 1996
    Date of Event
    July 1, 1992
    Report Date
    September 24, 1996
    Manufacturer
    MAMMARY IMPLANT, GEL-FILLED
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT ALLEGES RECEIVING BREAST IMPLANTS ON 4/14/79. PT ALSO ALLEGES HAVING REMOVAL IN 7/92 BECAUSE HER IMPLANTS RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC MAMMARY IMPLANT Implant MAMMARY IMPLANT, GEL-FILLED FTR MAMMARY IMPLANT, GEL-FILLED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention