BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 20515963 · Received October 23, 2024

    Report

    Report Number
    1645337-2024-12291
    Event Type
    Injury
    Date Received
    October 23, 2024
    Date of Event
    September 23, 2024
    Report Date
    October 18, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001263
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE UDI IS NOT AVAILABLE. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON OCTOBER 29, 2024, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE IMPACTED DEVICE WAS UPDATED TO A 350CC MENTOR SMOOTH ROUND MODERATE PROFILE (CATALOG NUMBER 3501655) WITH LOT NUMBER 223399. ON OCTOBER 31, 2024, MENTOR RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S REPLACEMENT DEVICE WAS A 390CC MENTOR MEMORYGEL BOOST BREAST IMPLANT WITH LOT NUMBER 9986129. ON NOVEMBER 14, 2024, THE EVALUATION FOR THE DEVICE WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING THE VISUAL ANALYSIS OF THE RETURNED SAMPLE SAL SMOOTH RND DIAP 350CC BREAST IMPLANT, NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED, ACCORDING TO THE MENTOR PROCEDURE, AND IT REVEALED (2) TWO TEARS ON THE POSTERIOR ASPECT AND (1) ONE TEAR ON THE ANTERIOR ASPECT OF THE SAL SMOOTH RND DIAP 350CC BREAST IMPLANT, MEASURING APPROXIMATELY 0.2 CM TEAR (A), 0.3 CM TEAR (B), AND 0.3 CM TEAR (C). MICROSCOPIC EXAMINATION WAS PERFORMED ON THE EDGES OF THE RUPTURES, AND PARALLEL STRIATIONS WERE FOUND IN THE WHOLE AREA OF THE TEARS. PARALLEL STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP OBJECT PERFORATING THE IMPLANT SHELL. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A MICROSCOPIC EXAMINATION OF THE RETURNED PRODUCT INDICATES THAT THE IMPLANT COULD HAVE BEEN DAMAGED DURING OR SUBSEQUENT TO IMPLANTATION. THE PRODUCT INSERT DATA SHEET CAUTIONS NOT TO ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS, OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS REQUIRED NOW. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. D4: UDI: UDI UNAVAILABLE, PRODUCT MADE PRIOR TO UDI COMPLIANCE DATE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 48-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION WITH AN UNSPECIFIED SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024. MENTOR IS FOLLOWING UP TO GATHER ADDITIONAL INFORMATION REGARDING THE IMPACTED DEVICE. IF ADDITIONAL INFORMATION IS RECEIVED, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317130 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 223399 00081317001263

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention