BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 9569784 · Received January 9, 2020

    Report

    Report Number
    1645337-2020-00565
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    December 17, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001669
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 02/11/2020, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AND MENTOR BECAME AWARE THAT THE SUSPECTED MEDICAL DEVICE WAS FOR THE CONTRALATERAL SIDE, INITIALLY REPORTED AS THE CONCOMITANT PRODUCT: (RIGHT) 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE CATALOG: 3503330 LOT: 6973573 SN: (B)(6). 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. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED A DEFLATION ON THE BREAST IMPLANT. DURING VISUAL INSPECTION OF THE DEVICE A CREASE WAS NOTED ON THE POSTERIOR ASPECT. ALSO A TEAR WAS OBSERVED WITHIN THE CREASE MEASURING APPROXIMATELY 0.2 CM. THE EVALUATION DETERMINED THAT THE RUPTURE IS CONSISTENT WITH A CREASE FOLD RUPTURE. THESE KIND OF FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDERINFLATION OR OVERINFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH A TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. 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 · 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: DEFLATION CONCOMITANT MEDICAL PRODUCTS: (RIGHT) 330CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE CATALOG: 3503330 LOT: 6973573 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES, SUFFERED DEFLATION POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33482 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3503420 6973573 00081317001669

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention