BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 9711085 · Received February 14, 2020

    Report

    Report Number
    1645337-2020-02401
    Event Type
    Injury
    Date Received
    February 14, 2020
    Report Date
    January 22, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER CLINICAL/SECONDARY REVIEW OF THIS FILE PERFORMED ON 2/14/2020, IT WAS DECIDED TO ADD BREAST PAIN TO MORE ACCURATELY CAPTURE THE REPORTED EVENT. LEFT SIDE BREAST PAIN WAS REPORTED. HOWEVER, SINCE SIDES ARE NOT SPECIFIED, BREAST PAIN CODE IS BEING ADDED TO BOTH SIDES. THIS REPORT IS FOR THE PATIENT¿S SIDE IMPLANTED WITH UNKNOWN SALINE IMPLANT. 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: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA HEALTH CANADA (190412) THAT A FEMALE PATIENT WITH UNKNOWN AGE AND RACE UNDERWENT UNSPECIFIED BREAST SURGERY WITH 300CC MENTOR SMOOTH ROUND MODERATE PROFILE ON ONE SIDE AND WITH AN UNKNOWN SIZE UNKNOWN SALINE IMPLANT ON THE OTHER SIDE AT AN UNKNOWN DATE AND EXPERIENCED PAIN IN THE LEFT BREAST, DIZZINESS, SEVERAL EPISODES OF DEPRESSION, CHRONIC FATIGUE, HEART PALPITATIONS, BETWEEN 111 AND 132 GASTROINTESTINAL PROBLEMS, MIGRAINE, AND ANXIETY. 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 SIDE IMPLANTED WITH UNKNOWN SALINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173744 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other