BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND HIGH PROFILE

    MDR report key: 8576175 · Received May 2, 2019

    Report

    Report Number
    1645337-2019-11011
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 10, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001676
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/17/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: THE ANALYSIS RESULTS SHOW THAT THE DEVICE APPEARED INTACT. LEAK TESTING REVEALED THERE WAS LEAKAGE FROM THE VALVE. NO ADDITIONAL ANOMALIES WERE OBSERVED. IT IS POSSIBLE THAT THE ROOT CAUSE OF THE RUPTURE WAS THE CAR ACCIDENT IN WHICH THE PATIENT WAS INVOLVED. THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION REPORTED AND/OR THE PRODUCT INVESTIGATION, THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH THE MANUFACTURING PROCESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 8/17/2019, 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. MENTOR BECAME AWARE THAT THE CORRECT DATE OF IMPLANTATION WAS (B)(6) 2003 AND THAT THE CORRECT DATE OF EXPLANTATION WAS (B)(6) 2019. IN ADDITION, MENTOR ALSO BECAME AWARE THAT THE PATIENT HAD UNDERGONE BILATERAL REMOVAL AND REPLACEMENT WITH THE FOLLOWING DEVICES: (LEFT) 700CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505700BC LOT: 7001387 SN: (B)(4) AND (RIGHT) 700CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3505700BC LOT: 7633398 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 5/26/2019, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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. ON(B)(6) 2019, MENTOR BECAME AWARE THAT THE DATE OF EXPLANTATION WAS RESCHEDULED ON (B)(6) 2019. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR BECAME AWARE THAT THE DATE OF EXPLANTATION WAS RESCHEDULED ON (B)(6) 2019. 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. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION, TRAUMATIC INJURY UNRELATED TO DEVICE. CONCOMITANT MEDICAL PRODUCTS: 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE CATALOG: 3503460 LOT: 233941. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION REVISION WITH TWO 460CC MENTOR SMOOTH ROUND HIGH PROFILE SALINE BREAST PROSTHESES, EXPERIENCED LEFT SIDE DEFLATION AFTER THEY WERE INVOLVED IN A VEHICLE COLLISION. AS A RESULT, THE PATIENT WAS SCHEDULED FOR IMPLANT EXPLANTATION AND REPLACEMENT WITH A 800CC MENTOR MEMORYGEL BREAST IMPLANT ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365735 MENTOR SMOOTH ROUND HIGH PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 233941 00081317001676

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention