BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8066340 · Received November 13, 2018

    Report

    Report Number
    1645337-2018-06801
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 4, 2018
    Report Date
    October 16, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000709
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. IT IS UNKNOWN AT THIS TIME IF THE DEVICE WILL BE MADE AVAILABLE FOR RETURN. AS A RESULT, 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 DEVICE HISTORY RECORD REVIEW IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, MENTOR BECAME AWARE THAT THE CORRECT LOT NUMBER FOR THIS SUSPECT MEDICAL DEVICE WAS 223174. ON (B)(6) 2018, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) -YEAR OLD (B)(6) FEMALE PATIENT WHO UNDERWENT REVISION AUGMENTATION WITH MENTOR MEMORYGEL BREAST IMPLANT 375CC GEL BREAST PROSTHESES IN 2002 PRESENTED WITH PNEUMONIA ON (B)(6) 2018, WHERE SHE WAS GIVEN A CT SCAN THAT SHOWED A LEFT SIDE DEVICE AND POSSIBLE RIGHT SIDE RUPTURES. THE PATIENT ALSO REPORTED SHE HAS HAD UNEXPLAINED MEDICAL CONDITIONS SINCE APPROXIMATELY 2017. SHE REPORTED UNEASY FEELING, LUNG NODULES, FATIGUE, BACK, NECK AND SHOULDER PAIN. CLOGGED EAR CANALS, COUGHING UP MUCUS, AND NODULES IN THE ARMPIT THAT EXUDE A WHITE EXUDATE. THE PATIENT BELIEVES SHE MAY HAVE BREAST IMPLANT ILLNESS AND MAY EXPLANT WITHOUT REPLACEMENT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906326 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 2243174 00081317000709

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention