BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND MODERATE PROFILE

    MDR report key: 8206503 · Received December 31, 2018

    Report

    Report Number
    1645337-2018-07675
    Event Type
    Injury
    Date Received
    December 31, 2018
    Date of Event
    December 11, 2018
    Report Date
    December 11, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001324
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 1/2/2019, IT WAS REPORTED TO MENTOR THAT THE DATE OF EXPLANTATION WAS (B)(6) 2019. ON (B)(6) 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 (B)(6) 2019, IT WAS REPORTED TO MENTOR THAT THE PATIENT¿S INITIALS WERE JRS. THE DATE PROBLEM OBSERVED WAS (B)(6) 2018. THE REPLACEMENT DEVICES WERE SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 700CC. THE PATIENT TOLERATED THE PROCEDURE WELL AND WENT INTO THE RECOVERY ROOM IN SATISFACTORY CONDITION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 2/7/2019, DEVICE EVALUATION AND INVESTIGATION FINDINGS: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. RED MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. MENTOR PRODUCT ANALYSIS LAB DISCOVERED A RENT MEASURING APPROXIMATELY 0.5 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 RED MATERIAL FOUND ON THE DEVICE. A MANUFACTURING RECORD EVALUATION (MRE) OF LOT NUMBER 5825388 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. CONCOMITANT PRODUCTS: SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 625 CC, CATALOG NUMBER 3501695, SERIAL NUMBER (B)(4), LOT NUMBER 5571901. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH SALINE MENTOR SMOOTH ROUND MODERATE PROFILE 625 CC BREAST IMPLANTS. THE PATIENT STARTED TO EXPERIENCE DISCOMFORT OF THE RIGHT BREAST IMPLANT ON (B)(6) 2018. THE PATIENT NOTICED THAT HER RIGHT BREAST IMPLANT WAS FLATTER ON (B)(6) 2018. THE PATIENT EXPERIENCED BREAST PAIN AND DEFLATION ON THE RIGHT BREAST IMPLANT. AS A RESULT, THE PATIENT WILL UNDERGO EXPLANTATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046371 MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 5825388 00081317001324

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention