BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 7927266 · Received October 2, 2018

    Report

    Report Number
    1645337-2018-05936
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    September 11, 2018
    Report Date
    September 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED WITH NO FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE AND ORANGE MATERIAL WAS OBSERVED ON SHELL SURFACE. DURING EVALUATION, DEVICE APPEARED INTACT. NO ANOMALIES WERE DISCOVERED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. A ROOT CAUSE FAILURE ANALYSIS WILL NOT BE CONDUCTED SINCE THE INVESTIGATION OF THE REPORTED FAILURE COULD NOT CONFIRM THAT AN ACTUAL FAILURE OF THE DEVICE TO CONFORM TO EXPECTED PERFORMANCE HAD OCCURRED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 190682 HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. AT THIS POINT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE AND ORANGE MATERIAL FOUND IN THE DEVICE. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 12/13/2018, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NO DOCUMENTATION WAS PROVIDED IN REGARDS TO THE DATE OF EXPLANTATION, SO THE DOE WAS DEFAULTED TO THE FIRST DAY OF THE MONTH THE DEVICE WAS RETURNED. 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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: UNKNOWN SALINE IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH UNKNOWN SALINE BREAST PROSTHESES. BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III/IV AND DEFLATION OF THE LEFT BREAST PROSTHESIS WERE CONFIRMED BY VISIBLE EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769588 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 190682

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other| R