BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 11809343 · Received May 11, 2021

    Report

    Report Number
    1645337-2021-05201
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    November 20, 2020
    Report Date
    May 10, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000198
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 6002053 NUMBER, AND NO NON-CONFORMANCES 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: CAPSULAR CONTRACTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 800CC AND SUFFERED FROM CAPSULAR CONTRACTURE BAKER GRADE IV AND RUPTURE SYMPTOMATIC ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAS UNDERGONE REMOVAL AND REPLACEMENT WITH NON-MENTOR DEVICE ON (B)(6) 2020. ON (B)(6) 2021, IT WAS REPORTED TO MENTOR THAT THE PATIENT EXPERIENCED BAKER GRADE IV CAPSULAR CONTRACTURE ON THE RIGHT SIDE BREAST. POSSIBLE LEFT SIDE RUPTURE SECONDARY TO TRAUMA ¿ CHEST INJURY- ((B)(6) 2020 ¿ SEVERE MOTORCYCLE ACCIDENT) , NOW WITH MALPOSITION AND CAPSULAR CONTRACTURE. THE REPLACEMENT DEVICES WERE ALLERGAN BRAND SCX GEL IMPLANTS. THE PATIENT HAD UNDERGONE REMOVAL OF LEFT RUPTURED SILICONE IMPLANT WITH SOME EXTRACAPSULAR SILICONE EXTRUSION, RECONSTRUCTION AND REPAIR OF LEFT PECTORALIS MAJOR MUSCLE ON (B)(6) 2020. THIS MEDWATCH IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701178 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3507800BC 6002053 00081317000198

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention