BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 8546730 · Received April 24, 2019

    Report

    Report Number
    1645337-2019-10569
    Event Type
    Injury
    Date Received
    April 24, 2019
    Report Date
    March 27, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001669
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    MEDWATCH NUMBER: MW5084650. IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY PROCEDURE WITH MENTOR MEDICAL DEVICES (SM HPS DV 420CC DATE OF IMPLANT (B)(6) 2013 ) HAS EXPERIENCED BILATERAL LYMPHADENOPATHY AND CAPSULAR CONTRACTURE ASSOCIATED WITH LEFT BREAST IMPLANT. THE PATIENT ALSO REPORTED UNEXPLAINED SYSTEMIC SYMPTOMS, WHICH INCLUDED BUT NOT LIMITED TO ¿EXTREME JAW, NECK, LYMPH NODE, EAR PAIN. I HAVE MIGRAINES EVERYDAY. CHRONIC FACIAL AND JAW PAIN, JOINT PAIN, SENSITIVITY TO LIGHT AND NOISES. MY PERFECTLY HEALTHY TEETH HURT, SEVERE BRAIN FOG AND BLURRY VISION. MY BEAUTIFUL SMOOTH SKIN HAS TURNED INTO BUMPY ECZEMA PATCHES. FORGETFULNESS AS I AM WRITING THIS, MY NAILS, AND TOENAILS ARE YELLOW AND CRUMBLING. OVARIAN CYSTS, DIAGNOSED WITH JBS IN 2016. CHEST AND RIB PAIN. SEVERAL GASTROINTESTINAL PROBLEMS AS WELL AS EXTREMELY HEAVY PERIODS.¿ NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD MORE INFORMATION BECOME AVAILABLE, THIS CASE WILL BE RE-ASSESSED AND NOTES WILL BE UPDATED. THIS REPORT IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339776 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 00081317001669

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S