BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMERA SILTEX HIGH PROFILE

    MDR report key: 7233150 · Received January 31, 2018

    Report

    Report Number
    1645337-2018-00647
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    October 23, 2017
    Report Date
    January 9, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P060028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. CONCOMITANT PRODUCTS: LUMERA SILTEX HIGH PROFILE 305CC GEL PROSTHESIS, CATALOG #324-1151, SERIAL #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 5613667 WAS REVIEWED ON 6/11/2018 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE UNDERWENT BREAST AUGMENTATION REVISION WITH A LUMERA SILTEX HIGH PROFILE 345CC GEL PROSTHESIS AND EXPERIENCED RUPTURE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75603 LUMERA SILTEX HIGH PROFILE PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention