BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    MDR report key: 9293605 · Received November 7, 2019

    Report

    Report Number
    1645337-2019-23381
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 10, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001423
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12/5/2019, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING VISUAL EVALUATION OF THE SAMPLE IT WAS OBSERVED A TEAR LOCATED IN THE UNION BETWEEN VALVE AND SHELL. MICROSCOPIC EXAMINATION WAS PERFORMED. NO EVIDENCE OF INSTRUMENT DAMAGE WAS OBSERVED. NO OTHER ANOMALIES WERE DISCOVERED. THE SECOND PRODUCT RECEIVED IS RELATED TO A CONCOMITANT DEVICE, THERE ARE NEITHER DEFICIENCIES ALLEGED NOR PATIENT INJURIES. THEREFORE NO FURTHER INVESTIGATION IS REQUIRED. DEFLATION IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. POSSIBLE CAUSES OF DEFLATION OF SALINE-FILLED IMPLANTS INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING EVENTS: EXCESSIVE STRESSES OR MANIPULATIONS AS MAY OCCUR DURING NORMAL, DAILY ROUTINES. 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. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION. CONCOMITANT PRODUCTS: (LEFT) 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE CATALOG: 3502375 LOT: 5983557 SN: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 375CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE SALINE BREAST PROSTHESES, SUFFERED RIGHT SIDE DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088315 MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5983557 00081317001423

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention