BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILASTIC MAMMARY IMPLANT, LPR, NFP

    MDR report key: 147688 · Received February 5, 1998

    Report

    Report Number
    1816403-1998-00043
    Event Type
    Injury
    Date Received
    February 5, 1998
    Date of Event
    December 16, 1997
    Report Date
    December 29, 1997
    Manufacturer
    DOW CORNING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GEL 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 SILASTIC MAMMARY IMPLANT, LPR, NFP Implant MAMMARY IMPLANT, GEL-FILLED FTR DOW CORNING CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention