BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 269218 · Received March 13, 2000

    Report

    Report Number
    269218
    Event Type
    Injury
    Date Received
    March 13, 2000
    Report Date
    January 14, 2000
    Manufacturer
    UNK
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    02/1988: BILATERAL BREAST CA DIAGNOSIS. 03/1988: BILATERAL MASTECTOMY WITH IMMEDIATE INSERTION OF TISSUE EXPANDERS. LATER IN 1988, REMOVAL OF TISSUE EXPANDER AND IMPLANT OF SILICONE BREAST IMPLANTS. 10/1999: MRI REVEALED "LEAKAGE OF MATERIAL FROM BOTH PROSTHESIS". IN 2000 EXCHANGE OF IMPLANTS BILATERAL BREASTS. OP NOTE STATES "DISINTEGRATED IMPLANTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SILICONE BREAST IMPLANT FTR UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention