BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8992619 · Received September 11, 2019

    Report

    Report Number
    1645337-2019-18757
    Event Type
    Injury
    Date Received
    September 11, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 13, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001782
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE RETURNED DEVICE WAS COMPLETED BY THE FAILURE ANALYSIS LAB ON 9/18/2019. DEVICE EVALUATION SUMMARY: ACCORDING TO THE REPORTED INFORMATION, THE PATIENT EXPERIENCED A DEFLATION IN THE BREAST SALINE IMPLANT. DURING EVALUATION OF THE SAMPLE IT WAS OBSERVED TO BE 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. DEFLATION, AS INDICATED IN THE PRODUCT INSERT DATA SHEET (PIDS), IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. 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. 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. 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 MEDICAL PRODUCTS: 425CC MENTOR SILTEX CONTOUR PROFILE MODERATE CATALOG: 3542914 LOT:7000878 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT BREAST AUGMENTATION REVISION SURGERY WITH A 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANT EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. THE LEFT SIDED DEFLATION WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH A 300CC MENTOR SMOOTH ROUND MODERATE PROFILE BREAST IMPLANTS (L) CATALOG: 3501645 LOT: 7737392 SN: (B)(4) AND A 425CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE R) CATALOG: 3502425 LOT: 7723088 SN: ((B)(4)) ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790878 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 7377337 00081317001782

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention