BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7306707 · Received March 1, 2018

    Report

    Report Number
    1645337-2018-01196
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    January 16, 2018
    Report Date
    January 31, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: SALINE MENTOR SMOOTH ROUND MODERATE PROFILE, 275 CC, CATALOG NUMBER 3501640, LOT NUMBER 267372, SERIAL (B)(4).

    Additional Manufacturer Narrative · 1

    ON 03/23/18, IT WAS REPORTED THAT THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN, BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON 03/29/18, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 267372 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. ON 04/11/2018, IT WAS REPORTED TO MENTOR THAT PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018 AND THE DATE OF ORIGINAL IMPLANT WAS (B)(6) 2005. AS A RESULT, THE BREAST IMPLANT WAS REPLACED WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 275CC, CATALOG NUMBER 3501640, LOT NUMBER 6840978, SERIAL NUMBER (B)(4). ON 04/16/2018, THE DEVICE EVALUATION WAS COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. BROWN 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 A RENT MEASURING APPROXIMATELY < 0.1 CM ON THE ANTERIOR ASPECT. MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT GAVE NO INDICATIONS AS TO CAUSE. NO OTHER ANOMALIES WERE DISCOVERED. THE COMPLAINT WAS CONFIRMED SINCE A RUPTURE WAS FOUND ON THE DEVICE. NONETHELESS, A MICROSCOPIC EXAMINATION OF THE EDGES OF THE RENT WAS PERFORMED AND IT DID NOT PROVIDE CONCLUSIVE EVIDENCE OF WHAT COULD BE THE ROOT CAUSE. AT THIS POINT IS NOT POSSIBLE TO DETERMINE THE ETIOLOGY OF THE BROWN MATERIAL FOUND ON THE DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE, 275 CC BREAST IMPLANTS AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. THE DEFLATION WAS DIAGNOSED DURING A PHYSICAL EXAMINATION BY A HEALTHCARE PROFESSIONAL ON (B)(6) 2018. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151119 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 267372

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention