BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 8177045 · Received December 18, 2018

    Report

    Report Number
    1645337-2018-07435
    Event Type
    Injury
    Date Received
    December 18, 2018
    Date of Event
    January 1, 2011
    Report Date
    November 28, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 12/23/2018, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. THE EXPLANTED DEVICE WAS REPLACED WITH A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS. ON 01/05/2019, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE SUSPECT MEDICAL DEVICE. IT IS A MENTOR SILTEX ROUND MODERATE PROFILE 425CC SALINE BREAST PROSTHESIS, CATALOG #3542670, LOT #263543, SERIAL NUMBER UNKNOWN, PMA #P990075, UDI (B)(4). A DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ON (B)(6) 2019, MENTOR ALSO RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE WAS A PRIMARY BREAST AUGMENTATION. THE IMPLANTATION DATE WAS INITIALLY REPORTED TO BE (B)(6) 2004. NEW INFORMATION STATES THAT THE IMPLANTATION DATE IS (B)(6) 2004. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, 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. 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. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE LEFT BREAST PROSTHESIS WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED MENTOR BREAST PROSTHESIS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014764 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 263543

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention