BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 12089676 · Received June 29, 2021

    Report

    Report Number
    1645337-2021-07361
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 9, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001256
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 20, 2021, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON AUGUST 4, 2021, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR THEN CONDUCTED A VISUAL INSPECTION, LEAK TEST, MICROSCOPIC EXAMINATION AND THICKNESS MEASUREMENT OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT SAL SMOOTH RND DIAP 325CC WAS FOUND TO HAVE A TEAR AT THE JUNCTURE BETWEEN THE SHELL AND PATCH OF THE DEVICE. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO ADDITIONAL TEAR WAS OBSERVED ON THE DEVICE. MICROSCOPIC EXAMINATION WAS PERFORMED AND THE CAUSE OF THE DEFLATION COULD NOT BE IDENTIFIED. THEREFORE A THICKNESS MEASUREMENT WAS CONDUCTED ON THE SHELL AT THE TEAR SITE, AND THE THICKNESS WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 5864206 AND NO NON-CONFORMANCES WERE IDENTIFIED. ALTHOUGH NO CONCLUSION COULD BE REACH ON THE CAUSE OF THE REPORTED EVENT, THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: CAUSES OF DEFLATION OF SALINE IMPLANTS INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: CREASE FOLD FAILURE, INTRAOPERATIVE OR POSTOPERATIVE TRAUMA, EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES INCLUDING CUSTOMARY AND PURPOSEFUL TRAUMA SUCH AS THAT WHICH CAN OCCUR DURING VIGOROUS EXERCISE, ATHLETICS, ETC. 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 · 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: 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 AUGMENTATION WITH A 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROTHESIS ON THE RIGHT BREAST, SUFFERED RIGHT BREAST IMPLANT DEFLATION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2021. THE REPLACEMENT DEVICES WERE THE FOLLOWING: (RIGHT) 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501670 LOT: 9542801 SN: (B)(4) AND (LEFT) 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE CATALOG: 3501670 LOT: 9542801 SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985656 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501650 5864206 00081317001256

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention