BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 9186485 · Received October 14, 2019

    Report

    Report Number
    1645337-2019-21641
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    August 23, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001829
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SUSPECT DEVICE RECEIVED ON 10/24/2019. DEVICE EVALUATION SUMMARY: THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND WITH NO APPARENT DAMAGE. LEAK TESTING REVEALED A TEAR NOTED IN THE ANTERIOR ASPECT MEASURING APPROXIMATELY 0.3 CM. NO OTHER ANOMALIES WERE OBSERVED. MICROSCOPIC EXAMINATION OF THE EDGES OF THE TEAR GAVE NO INDICATIONS OF INSTRUMENT DAMAGE. NO OTHER ANOMALIES OBSERVED. DEFLATION 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. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING 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. 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: DEFLATION. CONCOMITANT PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST IMPLANT, CAT#:3542670, LOT#: 222619. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE REPORT INDICATED THAT THE PATIENT EXPERIENCED PAIN. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT SCHEDULED FOR REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980295 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 222619 00081317001829

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention