BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE MODERATE

    MDR report key: 8308678 · Received February 5, 2019

    Report

    Report Number
    1645337-2019-08341
    Event Type
    Injury
    Date Received
    February 5, 2019
    Date of Event
    July 17, 2003
    Report Date
    January 8, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001867
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED ON 2/11/2019 INDICATED THE PATIENT EXPERIENCED BILATERAL DEFLATION AND UNDERWENT BILATERAL REMOVAL AND REPLACEMENT ON (B)(6) 2010. THE CONTRALATERAL DEVICE FOR THIS COMPLAINT IS AN UNKNOWN MENTOR SALINE BREAST IMPLANT. ON 2/13/2019, A MANUFACTURING RECORD EVALUATION (MRE) 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019. PATIENT RACE WAS IDENTIFIED AS CAUCASIAN. THE CONTRALATERAL DEVICE WAS IDENTIFIED AS A SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC, CATALOG NUMBER 3542912, LOT NUMBER 234081. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN AND DEFLATION OCCURRED ONLY ON THE RIGHT SIDE. THE DATE OF EVENT WAS IDENTIFIED AS (B)(6) 2003. 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 MANUFACTURING RECORD EVALUATION (MRE) IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 275CC BREAST IMPLANT AND EXPERIENCED DEFLATION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH SALINE MENTOR SILTEX CONTOUR PROFILE MODERATE 350CC, CATALOG NUMBER 3542913, SERIAL NUMBER (B)(4), LOT NUMBER 5976540 ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98515 MENTOR SILTEX CONTOUR PROFILE MODERATE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 234081 00081317001867

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention