BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8966487 · Received September 5, 2019

    Report

    Report Number
    1645337-2019-18381
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    August 7, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001232
    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 · 1

    DEVICE EVALUATION SUMMARY: ACCORDING TO THE REPORTED INFORMATION, THE PATIENT EXPERIENCED A DEFLATION IN THE BREAST IMPLANT. THE ANALYSIS RESULTS SHOW THAT THE DEVICE APPEARED INTACT. LEAK TESTING REVEALED THERE WAS LEAKAGE FROM THE VALVE. NO ADDITIONAL ANOMALIES WERE OBSERVED. THE ANALYSIS WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE LEAKING VALVE. EXCESSIVE MANIPULATION MAY HAVE CAUSED THE VALVE LEAK. THE IFU STATES ¿NOT TO MANIPULATE (I.E., SQUEEZE) THE VALVE EXCESSIVELY, WHICH MAY CAUSE VALVE LEAKAGE¿. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. BREAST IMPLANTS ARE NOT CONSIDERED LIFETIME DEVICES AND DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5980037, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE AND CAPSULAR CONTRACTURE BAKER GRADE 2-3. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A 275CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST IMPLANT (FOR RIGHT) AND AN UNKNOWN MENTOR SALINE BREAST IMPLANT (FOR LEFT) AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED DEFLATION AND BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE 2-3). THE DEFLATION WAS CONFIRMED BY A PHYSICIAN THROUGH VISUAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 375CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3503751BC, RIGHT SERIAL # (B)(4) AND LEFT SERIAL # (B)(4)ON (B)(6) 2019. THIS MEDWATCH REPORT IS FOR THE RIGHT-SIDED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759116 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5980037 00081317001232

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention