BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 11899207 · Received May 27, 2021

    Report

    Report Number
    1645337-2021-06045
    Event Type
    Injury
    Date Received
    May 27, 2021
    Report Date
    May 3, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 4, 2021, 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. MENTOR ALSO RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE CORRECT DATE OF EXPLANTATION WAS ON (B)(6) 2021. FOR LOT 233482: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 233482 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: 2001-OCT, EXPIRATION DATE: 2005-OCT. FOR LOT 232102: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 232102 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: 2001-SEP, EXPIRATION DATE: 2005-SEP. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JULY 1, 2021, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 375CC BREAST IMPLANT HAD A CREASE/FOLD ON THE POSTERIOR VIEW. ADDITIONALLY, A TEAR WAS OBSERVED WITHIN THE CREASE, MEASURING APPROXIMATELY 0.5 CM. LEAK TESTING WAS PERFORMED ACCORDING TO THE MENTOR PROCEDURE, AND NO ADDITIONAL LEAK SITES WERE DETECTED. THE EVALUATION DETERMINED THAT THE CAUSE OF THE RUPTURE IS CONSISTENT WITH NORMAL WEAR. 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 DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. IT SHOULD BE NOTED THAT AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ON JULY 2, 2021, MENTOR BECAME AWARE THAT THE FOLLOWING INFORMATION WAS ERRONEOUSLY OMITTED FROM THE SUPPLEMENTAL REPORT (FOLLOW UP REPORT 1) SENT ON JUNE 22, 2021: MENTOR RECEIVED INFORMATION SUGGESTING THAT THE DEFLATED IMPLANT WAS THE LEFT SIDE IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4) LEFT SIDE IMPLANT'S LOT NUMBER PROVIDED AND MANUFACTURING AND EXPIRATION DATES.

    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. FOR LOT 233482: A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. FOR LOT 232102: A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MATERIAL RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, SUFFERED BREAST IMPLANT DEFLATION ON AN UNSPECIFIED SIDE. SINCE IT IS UNKNOWN WHICH SIDE WAS THE DEFLATION, BOTH THE LEFT AND THE RIGHT BREAST IMPLANT'S LOT WILL BE PROVIDED (LEFT: 233482 RIGHT: 232102). A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN CLARIFICATION BECOMES AVAILABLE. AS A RESULT, THE PATIENT HAS BEEN SCHEDULED FOR IMPLANT EXPLANTATION SURGERY AND POSSIBLE MENTOR GEL IMPLANT REPLACEMENT ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792812 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501660 233482 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention