BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8941543 · Received August 28, 2019

    Report

    Report Number
    1645337-2019-18062
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    November 1, 2017
    Report Date
    January 29, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001270
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. WHITE MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY < 0.1 CM ON THE POSTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT REVEALED PARALLEL STRIATIONS. NO OTHER ANOMALIES WERE DISCOVERED. 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. 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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION CONCOMITANT MEDICAL PRODUCTS: SALINE MENNT TOR SMOOTH ROUND MODERATE PROFILE 375CC, CATALOG NUMBER 3501660, SERIAL NUMBER (B)(4), LOT NUMBER 5834571. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER IP-00069365. THIS DEVICE REPORT IS BEING SUBMITTED LATE AS A RESULT OF THE EXEMPTION TRANSITION PERIOD FOLLOWING THE REVOCATION OF MENTOR¿S ASR EXEMPTION #E1999017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 375CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2019. THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER IP-00069365.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736409 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5834571 00081317001270

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention