BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE BREAST IMPLANT

    MDR report key: 146650 · Received December 31, 1997

    Report

    Report Number
    146650
    Event Type
    Injury
    Date Received
    December 31, 1997
    Date of Event
    December 16, 1997
    Report Date
    December 29, 1997
    Manufacturer
    DOW CORNING CORP./MDR REPORTING & COMPLAINT INVESTIGATION
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GELL IMPLANT BLEED-THOUGHT TO BE A RUPTURED IMPLANT ON MRI. SURGICAL REMOVAL OF BILATERAL SILICONE FILLED BREAST IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE BREAST IMPLANT Implant IMPLANT FTR DOW CORNING CORP./MDR REPORTING & COMPLAINT INVESTIGATION NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention