BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE GEL WITH DEVICES AND IMPLANT SHELL ELASTOMER

    MDR report key: 8280 · Received July 21, 1994

    Report

    Report Number
    8280
    Event Type
    Injury
    Date Received
    July 21, 1994
    Date of Event
    July 11, 1988
    Report Date
    May 16, 1994
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BILATERAL BREAST IMPLANTS WERE INSERTED SURGICALLY ON 7/11/88. ON JANUARY 18, 1994, THE HOSPITAL RECEIVED CITATION FOR PENDING LAW SUIT. CLAIMANT IS CLAIMING BREAST PAIN, SKIN RASHES, HEADACHES, CHRONIC GATIGUE, MUSCLE SPASMS AND DIZZINESS. THERE IS NO HOSPITAL RECORD GRGARDING IMPLANTS BEING REMOVED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE GEL WITH DEVICES AND IMPLANT SHELL ELASTOMER Implant MAMMARY IMPLANTS DOUBLE LUMEN, 320/360 CC FTR MCGHAN MEDICAL CORP. STYLE 76 CV 4552, CR 8337

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other