BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK-MEDICAL ENGINEERING CORP

    MDR report key: 117208 · Received September 1, 1997

    Report

    Report Number
    MW1012013
    Event Type
    Injury
    Date Received
    September 1, 1997
    Date of Event
    April 29, 1997
    Report Date
    August 31, 1997
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEC 1996 ON MAMMOGRAM A SEVERE SILICONE RUPTURE WAS SHOWN. CAUSING SOME PAIN AND DISEASE SYMPTOMS. DRY EYES, ARTHRITIS JOINT SWELLING, LOSS OF HAIR, FATIGUE, MUSCLE ACHES, HAD 1ST SURGERY TO EXPLANT ON 4-29-97. BECAUSE OF SEVERE RUPTURE TO LEFT BREAST, A SUBCUTANEOUS MASTECTOMY WAS PERFORMED. THE RIGHT BREAST WAS FOUND TO BE RUPTURED AS WELL BUT HELD WITHIN CAPSULE. SCAR CAPSULES ALSO WERE REMOVED. 2ND RECONSTRUCTION SURGERY TO HAPPEN LATER THIS YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK-MEDICAL ENGINEERING CORP Implant SILICONE BREAST IMPLANTS FTR MEDICAL ENGINEERING CORP. 10600000S0 & 10580000S0 1127-81-A & 4420-81-L

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R