BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 9639855 · Received January 28, 2020

    Report

    Report Number
    1645337-2020-01440
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    July 5, 2008
    Report Date
    January 2, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER CLINICAL REVIEW OF THIS FILE PERFORMED ON (B)(6)2020, IT WAS DECIDED TO REMOVE CODE NO CODE AVAILABLE AND ADD AUTOIMMUNE DISORDER TO MORE ACCURATELY CAPTURE THE REPORTED EVENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON FEBRUARY 1, 2020, MENTOR BECAME AWARE OF THE PATIENT'S DATE OF BIRTH AND ETHNICITY/RACE. MENTOR ALSO BECAME AWARE THAT THE PATIENT EXPERIENCED GLUTEN ALLERGY, POSITIVE ANA TITERS FOR MIXED CONNECTIVE TISSUE DISEASE, SYSTEMIC CANDIDA AND TENDER BREAST MASSES ON THE RIGHT SIDE. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO BILATERAL DEVICE REMOVAL ON (B)(6) 2020. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: AUTOIMMUNE DISORDER AND BREAST LUMPS THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (VIA FDA MEDWATCH 5091690) THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH UNSPECIFIED SALINE MENTOR BREAST IMPLANTS AND EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING FOOD ALLERGIES, CHEMICAL SENSITIVITIES, DRY SKIN, DRY HAIR, BLOATING, FATIGUE, SEVERE MEMORY LOSS, LIFE ALTERING DEBILITATION, PHYSICALLY UNCONTROLLABLE PAIN, SLEEPING 10 HOURS PLUS A DAY, POOR BLURRED VISION, DAZED AND DRUNK FEELING 24/7, INABILITY TO FORM SENTENCES OR FIND WORDS, VERTIGO, INSOMNIA, TROUBLE CONCENTRATING, FREQUENT INFECTIONS, SEVERE DIGESTION ISSUES, GAS, SEVERE TINNITUS, CHRONIC CANDIDA, LEAKY GUT, CONSTIPATION, CAFFEINE SENSITIVITY, IRON DEFICIENCY, ANEMIA, SEVERE NIGHT SWEATS, CELIAC DISEASE, SHORTNESS OF BREATH, RAPID HEARTBEAT, SORE TONGUE, WHEEZING, PLEURISY, ITCHY RASHES, HEADACHES, HIVES, RANDOM CYSTS, CLOUDY URINARY ISSUES, OVERACTIVE BLADDER, THYROID CYSTS, TROUBLE SWALLOWING, SEVERE ANXIETY, DEPRESSION, STIFF NECK, NO LIBIDO, WHOLE BODY INFLAMMATION, JOINT PAIN, NUMBNESS AND TINGLING IN BOTH ARMS AND LEGS AND A LUMP ON THE NECK. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99024 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other| R