BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 9208217 · Received October 18, 2019

    Report

    Report Number
    1645337-2019-22045
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    September 14, 2019
    Report Date
    September 19, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 11/8/2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED A DEFLATION ON THE IMPLANT. DURING EVALUATION OF THE DEVICE A CREASE WAS NOTED ON THE POSTERIOR ASPECT. ALSO A TEAR WAS OBSERVED WITHIN THE CREASE MEASURING APPROXIMATELY 0.1 CM. NO OTHER ANOMALIES WERE OBSERVED. THESE KIND OF FINDINGS ARE CONSISTENT WITH A CREASE/FOLD FAILURE WHICH IS A KNOWN INHERENT RISK ASSOCIATED WITH THE USE OF SALINE-FILLED MAMMARY PROSTHESES AND MAY BE THE RESULT OF ONE OR MORE OF THE FOLLOWING CONTRIBUTING FACTORS: UNDERINFLATION OR OVERINFLATION OF THE DEVICE, CONTINUOUS AND SUSTAINED STRESSES TO THE DEVICE - SUCH A TOO SMALL A BREAST POCKET AND FOLDING OR WRINKLING OF THE SHELL IN THE BREAST POCKET. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE MENTOR FAILURE ANALYSIS LAB HAS 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. 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: DEFLATION. CONCOMITANT PRODUCTS: 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT CATALOG: 3501670 LOT: 5841538 SERIAL NUMBER: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT HAD UNDERGONE BILATERAL REMOVAL AND REPLACEMENT WITH A 525CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000921 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6662421 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention