BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7621713 · Received June 20, 2018

    Report

    Report Number
    1645337-2018-02475
    Event Type
    Injury
    Date Received
    June 20, 2018
    Date of Event
    December 28, 2017
    Report Date
    March 13, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001287
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MENTOR WITHOUT FLUID INSIDE. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. DURING VISUAL EXAMINATION OF THE DEVICE, THE PRODUCT EVALUATION TEAM (PE) OBSERVED A RENT ON THE POSTERIOR VIEW MEASURING 4.1 CM. MICROSCOPIC EXAMINATION OF THE RENT EDGES REVEALED PARALLEL STRIATIONS WHICH ARE SIMILAR TO MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING THE MATERIAL. NO OTHER ANOMALIES WERE FOUND. MENTOR PERFORMS 100% INSPECTION AND TESTING OF ALL DEVICES PRIOR TO RELEASE. AS A RESULT, PE CONCLUDED THAT THE RENT OCCURRED SOMETIME SUBSEQUENT TO THE REMOVAL OF THE DEVICE FROM ITS PROTECTIVE PACKAGING. THE COMPLAINT OF DEFLATION WAS CONFIRMED SINCE A RENT WAS FOUND ON THE DEVICE. MICROSCOPIC EXAMINATION REVEALED PARALLEL STRIATIONS ON THE EDGES OF THE RENT. THIS TYPE OF STRIATION IS MORE EVIDENT OF SHARP INSTRUMENT DAMAGE RATHER THAN SHELL FAILURE DUE TO WEAR. AT THIS POINT IS IT NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE WHITE MATERIAL OBSERVED. 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 AS REFERENCED IN OUR PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. NO FOREIGN MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PRODUCT EVALUATION DISCOVERED A RENT MEASURING APPROXIMATELY 4.1 CM ON THE POSTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT 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. 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. 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 SMOOTH ROUND MODERATE PROFILE 425CC SALINE, CATALOG #3501670, LOT #222721. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESES. BILATERAL DEFLATION WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH MENTOR MEMORYGEL BREAST IMPLANT 450CC GEL BREAST PROSTHESES ON (B)(6) 2018. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461432 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 221910 00081317001287

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention