BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 17687150 · Received September 5, 2023

    Report

    Report Number
    1645337-2023-10384
    Event Type
    Injury
    Date Received
    September 5, 2023
    Date of Event
    January 27, 2004
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000501
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON DEC 11, 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE IMPACTED PRODUCTS ARE MENTOR MEMORYGEL BREAST IMPLANTS 400CC, CATALOG NUMBER 3504004BC, LOT NUMBER 242973, SERIAL NUMBERS (B)(6) AND (B)(6). A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE MRE VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    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 MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DATE OF EXPLANTATION: ON (B)(6) 2023. REASON FOR DEVICE EXPLANT AND / OR REOPERATION: CAPSULAR CONTRACTURE, RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON JAN 3, 2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT ALSO EXPERIENCED NIPPLE DISCHARGE ON THE RIGHT SIDE. SURGICAL INTERVENTION WAS PERFORMED TO CORRECT THE ISSUE. THE DATE OF EVENT WAS IDENTIFIED AS JAN 27, 2004. THE DATE OF IMPLANTATION WAS IDENTIFIED AS (B)(6) 2002. THIS REPORT IS FOR THE RIGHT BREAST IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 60-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH UNSPECIFIED MENTOR GEL BREAST IMPLANTS AND EXPERIENCED BILATERAL CAPSULAR CONTRACTURE BAKER GRADE IV ALONG WITH BILATERAL RUPTURE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT IS SCHEDULED FOR REMOVAL ON (B)(6) 2023. THIS REPORT IS FOR THE FIRST OF TWO DEVICES. SEE MANUFACTURER REPORT NUMBER 1645337-2023-10387 FOR CONTRALATERAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831429 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 242973 00081317000501

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention