BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 11819997 · Received May 13, 2021

    Report

    Report Number
    1645337-2021-05207
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 28, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: MENTOR CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 325CC BREAST IMPLANT HAD A TEAR AT A JUNCTION AT THE VALVE SYSTEM. A MICROSCOPIC EXAMINATION WAS PERFORMED, AND THE CAUSE OF THE TEAR COULD NOT BE IDENTIFIED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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. A SECOND PRODUCT WAS RECEIVED (LOT-5943823). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. 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

    ON MAY 21, 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. 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: LEFT DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE AND EXPERIENCED LEFT SIDE BREAST IMPLANT DEFLATION POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3501660 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716012 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501650 5938925 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention