BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 19975418 · Received August 13, 2024

    Report

    Report Number
    1645337-2024-09450
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    June 12, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001225
    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

    ON OCT 11, 2024, 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. THE DEVICE CATALOG NUMBER WAS IDENTIFIED AS 3501635 AND THE LOT NUMBER WAS IDENTIFIED AS 5820447. 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: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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, LEAK TEST, MICROSCOPIC EXAMINATION, AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. DURING VISUAL ANALYSIS OF THE RETURNED SAMPLE, SAL SMOOTH RND DIAP 250CC NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR'S PROCEDURES. FINDINGS REVEALED A TEAR ON THE ANTERIOR VIEW, NEAR 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 TO 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).

    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. 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. D4: UDI: AS THE LOT/SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 425CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SIMILAR DEVICES ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640406 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5820447 00081317001225

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention