BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7542245 · Received May 24, 2018

    Report

    Report Number
    1645337-2018-03203
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    April 24, 2018
    Report Date
    May 1, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001805
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/26/2018, MENTOR BECAME AWARE THAT THE CORRECT DATE OF IMPLANT WAS (B)(6) 2009. MENTOR ALSO BECAME AWARE THAT THE REPLACEMENT DEVICES WERE: (RIGHT) MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL CATALOG: 3504254BC, LOT: 7575159, SN: (B)(4) AND (LEFT) MENTOR MEMORYGEL BREAST IMPLANT 425CC GEL CATALOG: 3504254BC, LOT: 7572384, SN: (B)(4). ON 6/27/2018, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. DEVICE INVESTIGATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE CONTAINED NO FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE OR ON THE SHELL SURFACE. EVALUATION OF THE DEVICE REVEALED A RENT MEASURING APPROXIMATELY 1.9 CM ON THE POSTERIOR ASPECT. MICROSCOPIC EXAMINATION REVEALED PARALLEL STRIATIONS WHICH ARE SIMILAR TO MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. NO OTHER ANOMALIES WERE OBSERVED. THE COMPLAINT OF DEFLATION WAS CONFIRMED. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE, PRODUCT EVALUATION CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. A POSSIBLE CAUSE OF THE FAILURE COULD NOT BE 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. 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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE CATALOG: 3542655 LOT: 5890548 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) AFRICAN AMERICAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESES. DEFLATION OF THE RIGHT BREAST PROSTHESIS WAS DETERMINED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR BILATERAL REMOVAL AND REPLACEMENT WITH UNKNOWN BREAST PROSTHESES ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382539 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5890548 00081317001805

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention