BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 9831690 · Received March 13, 2020

    Report

    Report Number
    1645337-2020-04164
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    November 12, 2019
    Report Date
    February 24, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001430
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT¿S LEFT-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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 FDA MEDWATCH 5092431) THAT A CAUCASIAN PATIENT OF UNKNOWN AGE UNDERWENT UNSPECIFIED BREAST SURGERY WITH 400CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE ON BOTH SIDES ON (B)(6) 2016 EXPERIENCED LEFT SIDE CAPSULAR CONTRACTURE; BAKER GRADE III, AND GENERALIZED ILLNESS INCLUDING VERTIGO, BRAIN FOG, CANNOT SLEEP, DIGESTIVE ISSUES, THYROID ISSUES, LIVER ELEVATED LEVELS, FOOD INTOLERANCES, AND RINGING IN THE EARS POSTOPERATIVELY. 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 LEFT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293825 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502400 6994999 00081317001430

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other