BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITEK

    MDR report key: 284098 · Received June 23, 2000

    Report

    Report Number
    MW1019211
    Event Type
    Injury
    Date Received
    June 23, 2000
    Report Date
    June 21, 2000
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BILATERAL BREAST AUGMENTATION IN 1989 WITH SURGITEK BI-LUMEN, LV-ROUND GEL/SALINE IMPLANTS. NO PROBLEMS EVER W/LT IMPLANT. 5/19/99 - BEGAN HAVING PAIN IN RT BREAST. PE = CLASS IV CAPSULE RIGHT AND CLASS II CAPSULE LEFT. PT HAD INCREASED PAIN RT BREAST AFTER MAMMOGRAM. 6/24/99 RT BREAST BIOPSY - NO CANCER. IN 1999 RT CAPSULECTOMY W/PLACEMENT OF IMPLANT. 12/10/99 CAPSULAR FORMATION RETURNING RT BREAST. IN 2000 PT UNDERWENT RT BREAST IMPLANT REMOVAL W/NO FURTHER RECONSTRUCTION AT THIS TIME. IMPLANT REMOVED INTACT W/NO APPARENT DEFECTS W/IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGITEK BREAST IMPLANTS FTR MEDICAL ENGINEERING CORP. LV ROUND Q5 STERILE 12941-88F

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention