BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9167724 · Received October 8, 2019

    Report

    Report Number
    1645337-2019-21146
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    May 1, 2019
    Report Date
    September 9, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000242
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11/27/2019 MENTOR BECAME AWARE THAT IT ERRONEOUSLY REFLECTED THE DEVICE AS NOT RETURNED IN THE INITIAL REPORT SUBMITTED. THE IMPACTED PRODUCT WAS IN FACT RECEIVED ON 9/24/2019. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 6954657, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 11/26/2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED THAT THE PATIENT DEVELOPED A WOUND INFECTION. DURING VISUAL EVALUATION OF THE SAMPLE, IT WAS FOUND RUPTURED. NO OTHER ANOMALIES WERE OBSERVED. PER A DATABASE QUERY, THIS IS THE ONLY REPORTED COMPLAINT OF INFECTION AGAINST LOT NUMBER 6954657. THE MENTOR MICROBIOLOGY DEPARTMENT HAS PROVIDED INFORMATION ON THE STERILITY LOT FOR THE IMPLANTED DEVICE INDICATING THAT IT MET ALL STERILIZATION PARAMETERS REQUIRED TO PROVIDE A 10E-6 STERILITY ASSURANCE LEVEL PRIOR TO RELEASE FOR DISTRIBUTION. THE MENTOR PRODUCT ANALYSIS LAB CONCLUDED THE REPORTED INFECTION OCCURRED FROM A SOURCE OTHER THAN THE DEVICE. INFECTION IS A KNOWN COMPLICATION ASSOCIATED WITH ANY SURGERY AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. AN INVESTIGATION OF THE RETURNED DEVICE WAS PERFORMED, AND MENTOR COULD NOT UNCOVER A DEVICE FAILURE THAT WE COULD CONNECT TO THE REPORTED MEDICAL SYMPTOMS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: INFECTION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH 200CC MENTOR MEMORYGEL BREAST IMPLANTS EXPERIENCED RIGHT SIDED BAKER¿S GRADE IV CAPSULAR CONTRACTURE AND LEFT SIDED INFECTION POST PROCEDURE. THE CAPSULAR CONTRACTURE WAS DIAGNOSED BY A PHYSICIAN. THE INFECTION HAS RESOLVED WITH UNKNOWN TREATMENT. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WITH 400CC MENTOR MEMORYGEL BREAST IMPLANTS WAS PERFORMED ON (B)(6) 2019. THIS REPORT RELATES TO THE LEFT PROSTHESIS. SEE 1645337-2019-21145 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960734 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6954657 00081317000242

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention