BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8254515 · Received January 16, 2019

    Report

    Report Number
    1645337-2019-07973
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 15, 2018
    Report Date
    December 25, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001225
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/5/2019, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 3/23/2019, IT WAS REPORTED TO MENTOR THAT THE DEVICE EVALUATION AND INVESTIGATION HAVE BEEN COMPLETED. UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. BROWN AND YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. WHITE MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 2.0 CM WITHIN A CREASE ON THE ANTERIOR ASPECT. 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, BROWN AND YELLOW MATERIAL FOUND ON THE DEVICE. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 7003534 WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE 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. BECAUSE MENTOR PRODUCT ANALYSIS LAB WAS UNABLE TO CONFIRM ANY UNUSUAL FAILURE MODE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. 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. NOTE: THE PATIENT¿S DATE OF BIRTH IS (B)(6), THE EXACT DATE OF BIRTH IS UNKNOWN. THE ADDRESS OF THE INITIAL REPORTER IS UNKNOWN, CLARIFICATION IS IN PROGRESS. (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 250CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. THE DEFLATION WAS DIAGNOSED VIA ULTRASONOGRAPHY. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH A SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 250CC ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46973 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 7003534 00081317001225

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention