BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 158240 · Received March 20, 1998

    Report

    Report Number
    MW1013332
    Event Type
    Injury
    Date Received
    March 20, 1998
    Report Date
    July 27, 1997
    Manufacturer
    MEDICAL ENGINEERING CORP./A BRISTOL MYERS SQUIB
    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

    A 52 YEAR OLD WHITE G3P3 FEMALE STATUS POST BILATERAL SUBGLANDULAR DOW CORNING GELS (QUESTION SIZE AND TYPE) FOR AUGMENTATION IN 1970. BECAME HARD IMMEDIATELY AND WERE REPLACED IN 1977 WITH SECOND SET OF GELS (NO RECORDS, AGAIN). HAD CLOSED CAPSULOTOMIES AT LEAST ONCE. 03/22/1980 HAD REPLACEMENT WITH SURGITEK BILUMENS, THINKS SUBMUSCULAR. RT WAS ALWAYS HARD. PT THINKS THEY'VE DECREASED IN SIZE AND COMPLAINS OF BILATERAL PAIN. NO HISTORY OF TRAUMA. RIGHT MRI. ARTHRALGIAS (POSITIVE AM STIFFNESS), MYALGIAS, PARESTHESIAS/DYPESTHESIAS, SPASMS, SWELLING, FATIGUE, SLEEP DISTURBANCES, SORE THROATS, FEVERS, HOT FLASHES/DRENCHING NIGHT SWEATS, HEADACHES, VISUAL CHANGES, DIZZINESS, MEMORY LOSS, DRY MUCOUS MEMBRANES, HAIR LOSS, RASHES, SENSITIVE TO SUN/COLD, ( POSITIVE RAYNAUD'S)/CHEM, SHORTNESS OF BREATH/ CHEST PAIN, CHOKING SENSATION, ELEVATED CHOLESTEROL, GASTROINTESTINAL/GENITOURINARY PROBLEMS, AND EASY BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK Implant * FTR MEDICAL ENGINEERING CORP./A BRISTOL MYERS SQUIB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| S