BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALINE FILLED BREAST IMPLANT

    MDR report key: 16946 · Received January 25, 1994

    Report

    Report Number
    16946
    Event Type
    Injury
    Date Received
    January 25, 1994
    Date of Event
    December 8, 1993
    Report Date
    December 16, 1993
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS HISTORY OF BREAST CARCINOMA, MASTESTOMY RADIATION (9/90). STAGED RECONSTRUCTION. 11/5/93 IMPLANT WAS EXPLANTED ON 12/8/93 BECAUSE OF RIGHT BREAST DEHISINCE, EXTRUSION OF IMPLANT. PHYSICIAN IMPLANTED SMALLER SIZE ON 12/8/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FILLED BREAST IMPLANT Implant FWM MCGHAN MEDICAL CORP 27-168451 450CC ROUND FY6953

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention