BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK GEL-FILLED MAMMARY IMPLANT

    MDR report key: 21915 · Received May 19, 1995

    Report

    Report Number
    MW1006018
    Event Type
    Injury
    Date Received
    May 19, 1995
    Date of Event
    January 1, 1986
    Report Date
    March 7, 1995
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED "HEART-ATTACK LIKE" PAIN AND SYMPTOMS. HEART FOUND TO BE NORMAL. HOSPITALIZED ON SEVERAL OCCASIONS. AFTER SEVERAL HOSPITALIZATIONS, PROBLEM WENT UNDIAGNOSED. DRS REMOVED PT'S GALLBLADDER IN AN ATTEMPT TO FIND CAUSE. SEVERE CHEST PAINS CONTINUED AFTER GALLBLADDER SURGERY. NOT KNOWN UNTIL 10/94 THAT THIS PAIN WAS KNOWN TO BE ASSOCIATED WITH BREAST IMPLANTS. PT ALSO HAS HISTORY OF OTHER RELATED EVENTS AND PROBLEMS: SEVERE DEPRESSION, CHRONIC FATIGUE, NON-SPECIFIC AUTO-IMMUNE CONDITION, ATYPICAL CONNECTIVE TISSUE DISEASE, ATYPICAL RHEUMATIC SYNDROME, PALMAR ERYTHEMA, NEUROLOGICAL PROBLEMS, GASTRO-INTESTINAL PROBLEMS, RUPTURE OF IMPLANT, SLEEP DISTURBANCES, ALOPECIA, PARESTHESIAS, CHRONIC COUGH, MULTIPLE ENVIRONMENTAL ALLERGIES, CHRONIC PAIN, MEMORY LOSS, CAPSULAR CONTRACTURE, MYOFASCITIS, CHRONIC BRONCHITIS, GENERALIZED OSTEOARTHRITIS, POLYARTHRITIS, DEGENERATIVE ARTHRITIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O| S