BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYSHAPE BREAST IMPLANT

    MDR report key: 12485641 · Received September 16, 2021

    Report

    Report Number
    1645337-2021-10369
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    January 1, 2018
    Report Date
    August 23, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317005094
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: AUTOIMMUNE DISORDER. EXPLANTATION DATE: (B)(6) 2021. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA 5102135 THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH TWO 445CC MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESES AND EXPERIENCED AUTOIMMUNE DISORDER POSTOPERATIVELY. THE PATIENT SUFFERED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING HEALTH DECLINE, WEAKNESS, FATIGUE, TREMORS, NEUROLOGICAL MOTOR ISSUES, MEMORY LOSS, LACK OF CONCENTRATION, DECREASED LIBIDO, BREAST PAIN, INSOMINIA, JOINT PAIN, LIMITED MOBILITTY, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), SINUS ISSUES, SKIN RASH, MIGRAINES, HAIR LOSS, VISION DISTURBANCES, MOOD CHANGES, INFLAMMATION, AND POSITIVE ANA. NO DEVICE ISSUE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT IS SCHEDULED TO UNDERGO EXPLANTATION ON (B)(6) 2021. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2018 BASED ON AVAILABLE INFORMATION. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380368 MENTOR MEMORYSHAPE BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3341309 7375130 00081317005094

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention