BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7507316 · Received May 11, 2018

    Report

    Report Number
    1645337-2018-02807
    Event Type
    Injury
    Date Received
    May 11, 2018
    Date of Event
    February 1, 2018
    Report Date
    April 16, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE CATALOG #3542655 LOT #23383. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 233839 HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. DEVICE INVESTIGATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. UPON INITIAL INSPECTION, THE DEVICE APPEARS INTACT. LEAK TESTING WAS PERFORMED ACCORDING WITH MENTOR PROCEDURES AND IT REVEALED THREE RENTS ON THE ANTERIOR ASPECT, MEASURING APPROXIMATELY 0.1 CM EACH ONE OF THEM. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENTS REVEALED PARALLEL STRIATIONS. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND IN THE DEVICE. MICROSCOPIC EXAMINATION REVEALED PARALLEL STRIATIONS. THIS TYPE OF STRIATIONS IS MORE CONCLUSIVE TO SHARP INSTRUMENT DAMAGE RATHER THAN SHELL FAILURE DUE TO WEAR. AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE YELLOW MATERIAL OBSERVED. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(4) -YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH MENTOR SILTEX ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESES. RIGHT BREAST PROSTHESIS DEFLATION WAS CONFIRMED BY PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 350CC SALINE BREAST PROSTHESIS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348931 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 233839 00081317001805

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention