BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 7220734 · Received January 25, 2018

    Report

    Report Number
    1645337-2018-00559
    Event Type
    Injury
    Date Received
    January 25, 2018
    Date of Event
    January 4, 2018
    Report Date
    January 4, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001812
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE IS STILL IMPLANTED. AS A RESULT, 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. CONCOMITANT MEDICAL PRODUCTS: MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS, CATALOG #354-2660, SERIAL # (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 2/21/2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 6991965 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).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED WITH AN OPERATIVE REPORT AND PROGRESS NOTES FROM THE REPLACEMENT SURGERY ON (B)(6) 2018. THE PROCEDURE BEING PERFORMED WHEN THE IMPACTED PRODUCT WAS INSERTED WAS BREAST AUGMENTATION. THE FINAL FILL VOLUME OF THE IMPACTED PRODUCT WAS 375CCS. THE PATIENT ALSO EXPERIENCED BILATERAL PTOSIS IN ADDITION TO DEFLATION. THE CONTRALATERAL PROSTHESIS WAS THOUGHT HAVE SHIFTED LATERALLY. ON (B)(6) 2018 BILATERAL PROSTHESIS REPLACEMENT WITH MENTOR SMOOTH ROUND MODERATE PROFILE 325CC SALINE PROSTHESES WAS PERFORMED. THE FINAL FILL VOLUME OF THESE PROSTHESES WAS 375CCS. NO PROCEDURAL COMPLICATIONS WERE NOTED. A PROGRESS NOTE FROM (B)(6) 2018 STATED THE PATIENT WAS STILL EXPERIENCING SOME DISCOMFORT, AND THE REPLACEMENT PROSTHESES WERE IN GOOD POSITION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE HAD A MENTOR SILTEX ROUND MODERATE PROFILE 375CC SALINE PROSTHESIS IMPLANTED AND EXPERIENCED DEFLATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63904 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 6991965 00081317001812

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention