BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 8933134 · Received August 26, 2019

    Report

    Report Number
    1645337-2019-17877
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    November 26, 2013
    Report Date
    July 30, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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 COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: GENERALIZED ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD UNKNOWN MENTOR SALINE PROSTHESES PLACED EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS POST PROCEDURE. LEFT BREAST PAIN / DISCOMFORT, SHORTNESS OF BREATH, HEART PALPITATIONS, THROAT CLEARING / CHRONIC COUGH, BURNING CHEST, COGNITIVE DYSFUNCTION (MEMORY BRAIN FOG, DIFFICULTY CONCENTRATING, WORD RETRIEVAL, MEMORY LOSS), CHRONIC FATIGUE, CHRONIC INFLAMMATION, WEIGHT GAIN AND INABILITY TO LOSE WITH HEALTHY DIET AND EXERCISE, SLOW MUSCLE RECOVERY AFTER WORKOUT, TEMPERATURE INTOLERANCE, EASY BRUISING, CHEMICAL SENSITIVITIES, MOOD SWINGS, ANXIETY AND PANIC ATTACKS, KNEE JOINT PAIN, LOW / NO LIBIDO, NIGHT SWEATS, INSOMNIA, TINGLING / NUMBNESS IN LEFT PINKY FINGER, PHOTOSENSITIVITY, GASTROINTESTINAL ISSUES, GENERAL MALAISE/FEELING EXTREMELY UNWELL, AUTOIMMUNE / SJOGREN'S SYNDROME SYMPTOMS: (SEVERE FATIGUE, DRY EYES, MOUTH, HAIR AND SKIN) WERE ALL NOTED. LAB TESTS AND LUNG FUNCTION TESTS WERE PERFORMED WITH NO CONCLUSIVE RESULTS. AS A RESULT, AN EXPLANT IS SCHEDULED FOR (B)(6) 2019. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. THIS EVENT WAS REPORTED TO THE FDA BY THE PATIENT UNDER MW5087835. SEE 1645337-2019-17878 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724129 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention