BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK TEARDROP GEL-FILLED MAMMARY IMPLANT

    MDR report key: 13400 · Received May 19, 1994

    Report

    Report Number
    MW1002124
    Event Type
    Injury
    Date Received
    May 19, 1994
    Date of Event
    May 1, 1992
    Report Date
    May 8, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A BILATERAL MASTECTOMY FOR CANCER IN 1987. SHE UNDERWENT BREAST RECONSTRUCTION SHORTLY THEREAFTER WITH EXPANDERS AND THEN BREAST IMPLANTS. THE PT COMPLAINED SUBSEQUENTLY OF SEVERE PAIN WITH BOTH BREAST IMPLANTS. ON PHYSICAL EXAMINATION THERE WAS A GRADE IV CAPSULAR CONTRACTURE ON THE RIGHT SIDE AND A GRADE V CAPSULAR CONTRACTURE ON THE LEFT SIDE. A SCAR OVERLAYING THE IMPLANT ON THE LEFT SIDE WAS DEPRESSED AND THERE WAS THIN SKIN OVERLAYING BOTH OF THE IMPLANTS. THE PT'S NIPPLES WERE LATERALLY DISPLACED. BECAUSE OF THE CAPSULAR CONTRACTURES, THE POSSIBILITY OF IMPLANT RUPTURES, AND THE INTENSE PAIN, THE IMPLANTS AND CAPSULES WERE REMOVED. (SAME PT REFERRED TO IN 1002125.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK TEARDROP GEL-FILLED MAMMARY IMPLANT Implant BREAST IMPLANT FTR MEDICAL ENGINEERING CORP. 89759-87-A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R