BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SMOOTH ROUND SPECTRUM

    MDR report key: 7544533 · Received May 25, 2018

    Report

    Report Number
    1645337-2018-03222
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 2, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317002017
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 7/2/2018, 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 7/19/2018, MENTOR BECAME AWARE THAT THE CORRECT SUSPECT MEDICAL DEVICE WAS MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE CATALOG: 3501470 LOT: 6900108. A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 7/26/2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. DEVICE INVESTIGATION SUMMARY: UPON RECEIPT BY MENTOR, THE DEVICE RETURNED WITHOUT FLUID. YELLOW MATERIAL WAS OBSERVED WITHIN THE DEVICE. NO FOREIGN MATERIAL WAS OBSERVED ON THE SHELL SURFACE. PRODUCT EVALUATION DISCOVERED A RENT MEASURING APPROXIMATELY 0.9 CM WITHIN A CREASE LOCATED ON THE POSTERIOR ASPECT. ALSO WERE NOTICED A PAIR OF CREASES ON THE POSTERIOR 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 YELLOW MATERIAL FOUND ON THE DEVICE. THE 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. 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. 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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON 6/7/2018, MENTOR BECAME AWARE THAT THE SUSPECT MEDICAL DEVICE REPORTED IN THE INITIAL REPORT SENT ON 5/25/208 AND ERRONEOUSLY INCLUDED IN THE FOLLOW UP REPORT SENT ON 6/28/2018 WAS INCORRECT. THAT PRODUCT WAS THE REPLACEMENT DEVICE: MENTOR SMOOTH ROUND SPECTRUM 425CC SALINE CATALOG: 3501470 LOT: 7521523 SN: (B)(4). THE CORRECT SUSPECT MEDICAL DEVICE IS AN UNKNOWN SALINE BREAST PROSTHESIS. THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE THAT WAS ERRONEOUSLY INCLUDED ON THE FOLLOW UP REPORT ON 6/28/2018 ALSO BELONGS TO THE REPLACEMENT DEVICE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 6/7/2018, 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 SPECTRUM 425CC SALINE BREAST PROSTHESES. DEFLATION ON THE RIGHT BREAST PROSTHESIS WAS DETERMINED. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH MENTOR BREAST PROSTHESIS ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387316 MENTOR SMOOTH ROUND SPECTRUM PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6900108 00081317002017

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention