BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 11989183 · Received June 13, 2021

    Report

    Report Number
    1645337-2021-06706
    Event Type
    Injury
    Date Received
    June 13, 2021
    Date of Event
    September 15, 2020
    Report Date
    May 20, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000518
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 14-JUN-2021, MENTOR BECAME AWARE OF DATA OMISSION ERROR IN THE INITIAL REPORT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4). A3. GENDER: FEMALE. G4. PMA/ 510(K): P030053.

    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 MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: IMPLANT EXCHANGE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT A BREAST AUGMENTATION REVISION WITH 425CC SMOOTH MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED RIGHT-SIDED IMPLANT RUPTURE POSTOPERATIVELY. THE RUPTURE WAS DISCOVERED WHEN THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH 500CC SMOOTH MENTOR MEMORYGEL BREAST IMPLANT, CATALOG # 3505004BC, LEFT LOT-SERIAL # (B)(4) AND RIGHT LOT-SERIAL # (B)(4) ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885359 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3504254BC 00081317000518

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention