BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10758491 · Received October 29, 2020

    Report

    Report Number
    1645337-2020-13866
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    September 1, 2020
    Report Date
    October 8, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    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

    ON 11/3/2020, IT WAS REPORTED TO MENTOR THAT THE AFFECTED DEVICES WERE LEFT SIDE: MENTOR MEMORYGEL BREAST IMPLANT 600CC, CATALOG NUMBER 3506004BC , SERIAL NUMBER (B)(6), LOT 6827989; RIGHT: MENTOR MEMORYGEL BREAST IMPLANT 600CC, CATALOG NUMBER 3506004BC , SERIAL NUMBER (B)(6), LOT 6831755. THE REPLACEMENT DEVICES WERE MENTOR MEMORYGEL BREAST IMPLANT 800CC. 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 · 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: GENERALIZED ILLNESS , DEFLATION, ACQUIRED DEFORMITY NOS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH AN UNSPECIFIED MENTOR SALINE BREAST IMPLANTS 600CC AND SUFFERED FROM GENERALIZED ILLNESS SYMPTOMS, BILATERAL DEFLATION, AND ¿RIGHT SIDE LOOKS CONCAVED BY CHEST AREA¿. THE PATIENT EXPERIENCED: ¿ HEAVY CHEST FEELS LIKE ELEPHANTS ARE LAYING ON CHEST, LETHARGIC AND TIRED, THERE IS NOT THE RIGHT AMOUNT OF OXYGEN GOING TO HEART, BLOOD PRESSURE WENT WAY UP¿. AS A RESULT, THE PATIENT IS GOING TO UNDERGO REMOVAL AND REPLACEMENT ON (B)(6) 2020. THIS MEDWATCH IS FOR THE RIGHT BREAST IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219306 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6831755

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention