BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9125729 · Received September 26, 2019

    Report

    Report Number
    1645337-2019-20257
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    June 1, 2012
    Report Date
    August 29, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000631
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER (B)(4), AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. 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: MATERIAL RUPTURE. CONCOMITANT MEDICAL PRODUCTS: 375CC MENTOR MEMORYGEL BREAST IMPLANT, CATALOG #3543757, LOT #253086, SERIAL #(B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 200CC MENTOR MEMORYGEL BREAST IMPLANT EXPERIENCED POTENTIAL LEFT SIDED RUPTURE POST PROCEDURE. THE PATIENT SUSPECTS THAT A CAR ACCIDENT MAY BE THE CAUSE. THE BREAST DID NOT SEEM AS FULL AS IT WAS BEFORE. AN OFFICIAL MEDICAL DIAGNOSIS IS UNKNOWN. AS A RESULT, THE PATIENT HAS A REPLACEMENT SURGERY PLANNED FOR (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920008 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 264721 00081317000631

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention