BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN MAMMARY IMPLANT, 240-280 CC

    MDR report key: 12125 · Received March 18, 1994

    Report

    Report Number
    MW1001159
    Event Type
    Injury
    Date Received
    March 18, 1994
    Date of Event
    December 1, 1991
    Report Date
    March 12, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 7/31/81, RPTR RECEIVED MAMMARY IMPLANTS FOR AUGMENTATION. SHE WAS 44 YRS OLD. ON 8/17/81 AND 8/31/81 HER BREASTS WERE SWOLLEN, RED AND INFLAMMED. THEY WERE FINE AFTER SHE TOOK TEGOPEN. ON 1/28/92 SHE HAD A NODULE ON HER RIGHT BREAST WHICH LATER DISAPPEARED. SHE HAS CAPSULAR CONTRACTURE OF BOTH BREASTS AND LOSS OF FEELING. IN 12/91, SHE HAD AN INFLAMMED RIGHT BREAST ("PERHAPS RELATED TO A 11/10/91 KIDNEY STONE"). FROM JANUARY TO OCTOBER 1992 SHE HAD JOINT PROBLEMS OF BOTH FEET AND HANDS. ON 10/92 MAMMOGRAM REVEALED A LEAK IN THE OUTER BAG OF THE RIGHT IMPLANT. FROM 12/92 TO PRESENT SHE HAS BEEN TREATED BY A RHEUMATOLOGIST FOR RHEUMATOID ARTHRITIS. ON 11/8/95, THE IMPLANTS OF 1981 (ONE OF WHICH HAD A RUPTURE IN THE OUTER, SALINE BAG) WERE EXPLANTED. THE DOCTOR FOUND NO SILICONE OUTSIDE OF THE IMPLANTS. HE IMPLANTED TWO ALL SALINE-FILLED MAMMARY IMPLANTS. RPTR UNDERSTANDS THAT THE EXPLANTED IMPLANTS WILL BE KEPT IN STORAGE FOR THREE MONTHS. SHE CONTINUES TO SUFFER FROM RHEUMATOID ARTHRITIS. WHETHER OR NOT IT IS RELATED TO THE IMPLANTS IS STILL UNKNOWN. EXPLANT DATE 11/8/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN MAMMARY IMPLANT, 240-280 CC Implant GEL-SALINE MAMMARY IMPLANT FTR MCGHAN MEDICAL CORP. STYLE 76 AF4265

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Not Applicable| L| R