BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 160623 · Received March 31, 1998

    Report

    Report Number
    MW1013404
    Event Type
    Injury
    Date Received
    March 31, 1998
    Report Date
    February 14, 1995
    Manufacturer
    MEDICAL ENGINEERING CORP. A BRISTOL MYERS SQUIBB CO.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BILATERAL RUPTURE OF GEL IMPLANTS (BILUMEN). A 65 YR OLD WHITE FEMALE G2P2 WITH HISTORY OF LEFT BIOPSY TIMES 3 IN 1970, 1979 AND 1980 FOR PAPILLOMA HAD INDETERMINATE PATHOLOGY ON RIGHT BIOPSY 6/19/80 AND CANCER ON LEFT FOR WHICH SHE HAD LEFT SIMPLE MASTECTOMY. SHE HAD A RIGHT MODIFIED RADICAL MASTECTOMY 7/18/80 FOR STAGE I CANCER (PATHOLOGY INDETERMINATE WITH SOME PATHOLOGISTS READING CANCER AND OTHERS BENIGN). LYMPH NODES POSITIVE NO EVIDENCE OF DISEASE. PT HAD BILATERAL SUBPECTORAL RECONSTRUCTION 10/16/80 WITH SURGITEK BILUMENS RIGHT 230:125, LEFT 230:110. PT COMPLAINS OF DECREASED SIZE WITH HISTORY OF TRAUMA 6 YRS PRIOR. SYSTEMIC COMPLAINTS OF ARTHALGIAS, MYALGIAS, PARESTHESIAS, FATIGUE, RIGHT HEADACHES, NEUROCOGNITIVE PROBLEMS, GASTROINTESTINAL AND GENITOURINARY DISTURBANCES. FAMILY HISTORY NEGATIVE FOR BREAST CANCER. SYMPTOMS 7/8/94 SHOWED BILATERAL RUPTURE WITH WIDELY TORN ENVELOPE LIQUID GEL, MARKED YELLOWING/CLOUDY MODERATE CAPSULAR SCAR WITH GRANULOMATOUS MODERATE HISTOCYTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK Implant BILUMEN SALINE BREAST IMPLANTS FTR MEDICAL ENGINEERING CORP. A BRISTOL MYERS SQUIBB CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| S