BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 7868963 · Received September 12, 2018

    Report

    Report Number
    1645337-2018-05521
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    August 1, 2018
    Report Date
    August 23, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001300
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PRODUCT EVALUATION DISCOVERED A RENT MEASURING APPROXIMATELY 0.3 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. HOWEVER, AT THIS POINT IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF SUCH DAMAGE OR THE ETIOLOGY OF THE WHITE AND YELLOW MATERIAL FOUND ON THE DEVICE. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 231430 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. 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. (B)(4).

    Additional Manufacturer Narrative · 0

    ON 9/17/2018,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, 9/17/2018, MENTOR BECAME AWARE THAT THE CORRECT DATE OF EVENT WAS (B)(6) 2018. MENTOR ALSO BECAME AWARE THAT THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH (LEFT) MENTOR SMOOTH ROUND MODERATE PROFILE 525CC SALINE CATALOG: 3501685 LOT: 6944105 SN: (B)(4) AND (RIGHT) MENTOR SMOOTH ROUND MODERATE PROFILE 525CC SALINE CATALOG: 3501685 LOT: 7580678 SN: (B)(4). 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. 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. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH MENTOR SMOOTH ROUND MODERATE PROFILE 525CC SALINE BREAST PROSTHESIS. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711765 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 231430 00081317001300

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention