BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPG 321

    MDR report key: 8501734 · Received April 10, 2019

    Report

    Report Number
    1645337-2019-10150
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    May 9, 2017
    Report Date
    March 13, 2019
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    Product Code
    FTR
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/26/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE PATIENT REPORTED ADDITIONAL UNEXPLAINED SYSTEMIC SYMPTOMS INCLUDING INFLAMMATION, FOOD INTOLERANCE, AND BLADDER ISSUES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 01/14/2020, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS MANUFACTURED IN MENTOR TEXAS USA. NEW INFORMATION STATES THAT THE SUSPECT MEDICAL DEVICE WAS MANUFACTURED IN MENTOR MEDICAL SYSTEMS B.V, LOCATED IN LEIDEN, NETHERLANDS. MENTOR MEDICAL SYSTEMS B.V, LOCATED IN LEIDEN, THE NETHERLANDS, IS A FOREIGN MANUFACTURER OF MEDICAL DEVICES THAT ARE NOT CLEARED OR APPROVED FOR SALE IN THE US. IT IS A SEPARATE LEGAL ENTITY FROM MENTOR TEXAS. PER 21 CFR 803.58 AND "MEDICAL DEVICE REPORTING FOR MANUFACTURERS" (FDA GUIDANCE DOCUMENT ISSUED ON NOVEMBER 8, 2016), WE ARE ¿NOT REQUIRED TO SUBMIT MDR REPORTS FOR EVENTS OCCURRING IN OTHER COUNTRIES FOR A DEVICE THAT IS MANUFACTURED IN A FOREIGN COUNTRY AND THAT IS NOT CLEARED OR APPROVED FOR MARKETING IN THE US. HOWEVER, IF MENTOR BECOMES AWARE OF INFORMATION THAT REASONABLY SUGGESTS A DEVICE HAS MALFUNCTIONED AND THAT A SIMILAR DEVICE THAT IS MARKETED IN THE US WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR, THEN MENTOR SHOULD REPORT THE DEVICE MALFUNCTION THAT OCCURRED OUTSIDE THE US." SINCE MENTOR MEDICAL SYSTEMS B.V. DO NOT MARKET ANY DEVICES IN THE US, MANUFACTURE & MARKET ALL THEIR DEVICES OUTSIDE THE US, AND HAVE NEVER HELD FDA APPROVAL NOR CLEARANCE FOR ANY OF THEIR PRODUCTS, THEIR DEVICES DO NOT MEET THE CRITERIA FOR MDR REPORTABILITY. MANUFACTURER CONTACT PHONE NUMBER: (B)(4). MANUFACTURER SITE FAX: (B)(4). MANUFACTURER SITE PHONE: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION (MRE) COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT AN UNKNOWN PROCEDURE WITH UNSPECIFIED MENTOR GEL BREAST PROSTHESES IN 2003 DEVELOPED THE FOLLOWING: PAIN IN RIBCAGE AND UPPER BACK, PERIODIC PAIN IN LEFT GROIN AND DOWN LEFT LEG, PAIN & BURNING SENSATION IN BREASTS AND LEFT BREAST PUCKERING, LOSS OF BLADDER CONTROL, LOSS OF SENSE OF SMELL, COGNITIVE DYSFUNCTION (MEMORY LOSS, LOSS OF CONCENTRATION & BRAIN FOG), VISUAL DISTURBANCES, VERTIGO, CHEST PAIN AND PRESSURE, SUDDEN CHANGES IN HEART RATE, HEART PALPITATIONS, ADRENAL SYMPTOMS (FIGHT OR FLIGHT), ANXIETY/DEPRESSION, PANIC ATTACKS, CHRONIC HEADACHES, PAIN IN THE BACK OF THE HEAD, BACK OF NECK PAIN ISSUES, SLEEP DISTURBANCES, GASTROINTESTINAL ISSUES, MUSCLE AND JOINT PAIN, CHRONIC FATIGUE, HAIR LOSS, DARK BLOTCHES ON FACE (HORMONE DISRUPTION), LOW LIBIDO, CRAMPING AND EXCESSIVE BLEEDING DURING MENSTRUAL CYCLE, EXCESSIVE BRUISING AND SLOW HEALING CUTS, DIFFICULTY SWALLOWING, ACID REFLUX, EAR RINGING, TMJ, NIGHT SWEATS, AND NUMBNESS IN EXTREMITIES. AS A RESULT, THE PATIENT HAD THE PROSTHESES REMOVED ON (B)(6) 2017. THIS MEDWATCH REPORT IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294162 CPG 321 PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. L35917

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention