BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 8668994 · Received June 4, 2019

    Report

    Report Number
    1645337-2019-13232
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 8, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001645
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS REPORTED TO THE FDA IN FOLLOW UP REPORT #1 THAT THE SUSPECT MEDICAL DEVICE FOR THIS COMPLAINT IS A NON MENTOR DEVICE. NEW INFORMATION STATES THAT THE SUSPECT MEDICAL DEVICE IS A MENTOR PRODUCT. IT IS THE PRODUCT THAT WAS REPORTED TO THE FDA IN THE INITIAL REPORT, A MENTOR SMOOTH ROUND HIGH PROFILE 330CC SALINE BREAST PROSTHESIS, CATALOG #3503330, LOT #5581001, SERIAL #(B)(4), PMA #P990075, UDI #(B)(4). ON 06/26/2019, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. ON 07/12/2019, MENTOR COMPLETED THE INVESTIGATION ON THE SUSPECT MEDICAL DEVICE. DEVICE EVALUATION SUMMARY: ACCORDING TO THE REPORTED INFORMATION, THE PATIENT EXPERIENCED A DEFLATION IN THE BREAST IMPLANT. THE ANALYSIS RESULTS SHOWED A CREASE RUNNING FROM THE ANTERIOR TO THE POSTERIOR ASPECT. LEAK TESTING WAS PERFORMED AND NO LEAK SITES WERE DETECTED. NO ADDITIONAL ANOMALIES WERE OBSERVED. THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. 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. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    MENTOR RECEIVED ADDITIONAL INFORMATION THAT THE SUSPECT MEDICAL DEVICE FOR THIS EVENT IS NOT A MENTOR PRODUCT. AS A RESULT, NO INVESTIGATION WILL TAKE PLACE. 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 (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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION OF RIGHT BREAST PROSTHESIS. CONCOMITANT MEDICAL PRODUCTS: MENTOR SMOOTH ROUND HIGH PROFILE 330CC SALINE BREAST PROSTHESIS, CATALOG #3503330, SERIAL #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR SMOOTH ROUND HIGH PROFILE 330CC SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS CONFIRMED BY A PHYSICIAN UPON EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461956 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5581001 00081317001645

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention