BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8833785 · Received July 26, 2019

    Report

    Report Number
    1645337-2019-16006
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    October 2, 1998
    Report Date
    June 28, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000686
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON (B)(6) 2019, MENTOR BECAME AWARE OF THE DEVICE'S MANUFACTURING AND EXPIRATION DATES AS WELL AS INFORMATION INDICATING THE PATIENT EXPERIENCED GRANULOMA. 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

    ADDITIONAL INFORMATION: ON 11/27/2019, MENTOR BECAME AWARE THAT THE PATIENT EXPERIENCED BILATERAL RUPTURE AND CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL AND REPLACEMENT WITH 200CC MENTOR MEMORYGEL BREAST IMPLANTS, CATALOG NUMBER 3502001BC, SERIAL NUMBERS (B)(4) ON THE LEFT SIDE AND (B)(4) ON THE RIGHT SIDE ON (B)(6) 2019. THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE AND CAPSULAR CONTRACTURE THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE. 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 IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. CONCOMITANT PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 325CC, CATALOG # 3543257, LOT # 172780. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR MEMORYGEL BREAST IMPLANT 325CC AND EXPERIENCED RUPTURE ON THE LEFT SIDE POST-OPERATIONAL. THE RUPTURE WAS DIAGNOSED VIA A BIOPSY PERFORMED 10 YEARS AGO THAT SHOWED FREE SILICONE IN THE PATIENT¿S AXILLA. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627667 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 172780 00081317000686

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention