BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 10673040 · Received October 13, 2020

    Report

    Report Number
    1645337-2020-12985
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 22, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001249
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 16, 2020, MENTOR COMPLETED EVALUATION OF THE DEVICE. DEVICE EVALUATION SUMMARY: DURING VISUAL EVALUATION, TWO ANOMALIES WERE OBSERVED ON THE DEVICE CONSISTENT WITH A CREASE/FOLD IN THE ANTERIOR VIEW AND EXTENDING TO POSTERIOR VIEW. A TEAR WAS ALSO OBSERVED WITHIN ONE OF THE CREASE/FOLD, IN THE ANTERIOR VIEW, MEASURING APPROXIMATELY 0.1 CM. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD DEFLATION OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF SALINE-FILLED MAMMARY PROSTHESIS. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN A DEFLATION IN A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. A SECOND PRODUCT WAS RECEIVED (LOT-5871330). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. DEFLATION COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY MENTOR QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, THE MENTOR FAILURE ANALYSIS LAB 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. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR SMOOTH ROUND MODERATE PROFILE 300CC SALINE BREAST PROTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136576 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501645 5905324 00081317001249

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention