BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 15981794 · Received December 14, 2022

    Report

    Report Number
    1645337-2022-15066
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    October 7, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JAN 13, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED A MENTOR SMOOTH ROUND MODERATE PROFILE, CATALOG NUMBER 3501670, LOT NUMBER 7010893 FOR EVALUATION. ON JAN 26, 2023, THE DEVICE WAS IDENTIFIED AS THE IMPACTED PRODUCT. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED A VISUAL INSPECTION, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. DURING VISUAL ANALYSIS OF THE RETURNED SAMPLE SAL SMOOTH RND DIAP 425CC, A TEAR WAS OBSERVED AT THE UNION BETWEEN THE SHELL AND THE VALVE SYSTEM. MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. THEREFORE A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR, AND THE THICKNESS WAS WITHIN MANUFACTURING SPECIFICATIONS. ALTHOUGH NO CONCLUSION COULD BE REACHED ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: ACCORDING WITH THE PRODUCT INSERT DATA SHEET, THE VALVE SYSTEM CAN BE DAMAGED BY IMPROPER USE OF THE FILL-TUBE STYLET. CARE SHOULD BE TAKEN THAT THE STYLET ENTERS THE VALVE SMOOTHLY. USE THE THUMB AND FOREFINGER TO STABILIZE/SUPPORT THE VALVE SEAT AND GENTLY PUSH THE STYLET TIP INTO THE VALVE OPENING. OVERSTRESSING THE VALVE MATERIAL MAY RESULT IN PUNCTURES OR TEARS AND SUBSEQUENT DEFLATION MAY OCCUR. USE ONLY THE FILL TUBE STYLET PROVIDED WITH THIS PRODUCT. TAKE CARE NOT TO PUNCTURE THE DIAPHRAGM VALVE OR THE SHELL WITH THE STYLET TIP. CARE MUST ALSO BE TAKEN WHEN THE FILL TUBE STYLET IS REMOVED TO PREVENT DAMAGE TO THE VALVE ASSEMBLY. AS PART OF MENTOR¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH SALINE MENTOR SMOOTH ROUND MODERATE PLUS PROFILE 425CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR GEL BREAST IMPLANTS ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463235 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3502425 7010893 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention