BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS SMOOTH

    MDR report key: 9829695 · Received March 13, 2020

    Report

    Report Number
    1645337-2020-04153
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    October 16, 2018
    Report Date
    February 19, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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: AUTOIMMUNE DISORDER AND CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED (VIA FDA MEDWATCH 5092375), THAT A FEMALE PATIENT UNDERWENT BREAST AUGMENTATION WITH UNSPECIFIED SALINE MENTOR SMOOTH BREAST IMPLANTS AND EXPERIENCED SEVERAL UNEXPLAINED SYSTEMIC SYMPTOMS, INCLUDING NUMBNESS IN ARMS, NUMBNESS IN LEGS, DEPRESSION, ANXIETY, FATIGUE, HAIR LOSS, DIFFICULTY BREATHING, AUTOIMMUNE DISEASE, CHEST PAIN, CHILLS, CHRONIC PAIN, HEADACHES, RASH, HORMONAL CONCERNS, NEUROLOGICAL DISTURBANCES, PROBLEMS SLEEPING, SENSITIVITY TO LIGHT AND SUN, INFLAMMATION AND BILATERAL CAPSULAR CONTRACTURE. NO DEVICE ISSUE SUCH AS RUPTURE WAS REPORTED. THE ROOT CAUSE OF THE PATIENT¿S SYMPTOMS IS UNCLEAR. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295001 UNKNOWN SALINE IMPLANTS SMOOTH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention