BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEL MOD-RND 600CC

    MDR report key: 7398121 · Received April 4, 2018

    Report

    Report Number
    1645337-2018-01818
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 9, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000174
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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: GEL MENTOR MEMORYGEL BREAST IMPLANTS 600CC, CATALOG NUMBER 3507600BC, LOT NUMBER 225225. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    ON 04/24/2018, IT WAS REPORTED TO MENTOR THAT THE DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 230621 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE OF UNKNOWN TYPE WITH GEL MENTOR MEMORYGEL BREAST IMPLANTS 600CC AND EXPERIENCED RUPTURE ON THE RIGHT BREAST IMPLANT. LEFT BREAST IMPLANT WAS NOT AFFECTED. AS A RESULT, THE PATIENT HAD UNDERGONE BILATERAL REMOVAL AND REPLACEMENT WITH GEL MENTOR MEMORYGEL BREAST IMPLANT 400CC ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240333 GEL MOD-RND 600CC PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 230621 00081317000174

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention