BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 10131424 · Received June 8, 2020

    Report

    Report Number
    1645337-2020-07063
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    March 27, 2020
    Report Date
    May 18, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001263
    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

    ON SEPTEMBER 28, 2020, MENTOR BECAME AWARE THAT THE PATIENT ALSO SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. IN ADDITION, MENTOR ALSO BECAME AWARE THAT THE PATIENT UNDERWENT BILATERAL REPLACEMENT WITH TWO NON-MENTOR SILICONE GEL IMPLANTS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Additional Manufacturer Narrative · 0

    ON JUNE 18, 2020, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. MENTOR BECAME AWARE THAT THE CORRECT DATE OF IMPLANT EXPLANTATION SURGERY WAS ON (B)(6) 2020. ON JUNE 26, 2020, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING THE VISUAL EVALUATION, AN ANOMALY WAS OBSERVED ON THE ANTERIOR AND POSTERIOR VIEWS OF THE DEVICE CONSISTENT WITH A CREASE/FOLD. LEAK TESTING WAS PERFORMED, ACCORDING WITH MENTOR PROCEDURE, AND IT REVEALED IN ANTERIOR VIEW A TEAR WITHIN THE CREASE/FOLD MEASURING APPROXIMATELY 0.1 CM. THE EVALUATION DETERMINED THAT THE LOSS OF SHELL INTEGRITY IS CONSISTENT WITH A CREASE FOLD DEFLATION OF THE IMPLANT SHELL, WHICH IS A KNOWN INHERENT RISK OF THE SALINE-FILLED MAMMARY PROSTHESIS. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. CREATING WRINKLES OR FOLDS SHOULD BE AVOIDED DURING IMPLANTATION OR OTHER PROCEDURES AS IT CAN RESULT IN DEFLATION AT A LATER TIME. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. A SKIN REACTION IS A NOTICEABLE CHANGE IN THE TEXTURE AND/ OR COLOR OF THE SKIN. THIS CAN INCLUDE BUMPS, SCALES, PUSTULES OR REDNESS THAT CAN BE INFLAMED, IRRITATED, PAINFUL, OR ITCHY. THIS CAN BE DUE TO A VARIETY OF FACTORS SUCH AS INFECTIONS, HEAT, ALLERGENS OR IMMUNE SYSTEM DISORDERS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS 6853020 LOT NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. 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, SKIN IRRITATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH TWO 350CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES, SUFFERED BILATERAL BREAST IMPLANT DEFLATIONS, POST-OPERATIVELY. THE PATIENT ALSO EXPERIENCED WELTS ALL OVER THEIR BODY, WHICH THEY BELIEVE IS DUE TO THE SALINE IMPLANTS AND THEIR BODY REJECTING THE IMPLANTS. THE DEFLATIONS WERE DIAGNOSED VIA MAMMOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL IMPLANT EXPLANTATION ON (B)(6) 2020. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591912 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3501655 6853020 00081317001263

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention