BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 17819181 · Received September 26, 2023

    Report

    Report Number
    1645337-2023-11367
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    November 28, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEP 29, 2023, THE MENTOR FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. DEVICE EVALUATION SUMMARY: THE PRODUCT WAS RETURNED TO MENTOR FOR EVALUATION. MENTOR CONDUCTED VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE SAL SMOOTH RND DIAP 375CC BREAST IMPLANT HAD AN AREA OF SHELL ABRASION ON THE POSTERIOR VIEW. LEAK TESTING WAS PERFORMED, ACCORDING TO MENTOR PROCEDURE, AND IT IDENTIFIED A TEAR WITHIN THE SHELL ABRASION MEASURING APPROXIMATELY LESS THAN 0.1 CM. ADDITIONALLY, NO OTHER LEAK SITES WERE DETECTED. THE EVALUATION DETERMINED THAT THE POSSIBLE CAUSE OF THE DEFLATION IS CONSISTENT WITH NORMAL WEAR. SHELL ABRASION SUGGEST IN-VIVO FOLDING OR CREASING OF THE DEVICE. THIS MAY BE THE RESULT OF THE CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE. A SECOND PRODUCT WAS RECEIVED LOT 5760506. 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

    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. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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 AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 375CC 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 ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018797 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5760506 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention