BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8356218 · Received February 20, 2019

    Report

    Report Number
    1645337-2019-08738
    Event Type
    Injury
    Date Received
    February 20, 2019
    Date of Event
    January 4, 2019
    Report Date
    January 25, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000730
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 5/6/2019, MENTOR BECAME AWARE THAT THE CORRECT DATE OF EVENT WAS (B)(6) 2019, WHEN AN MRI WAS PERFORMED AND IDENTIFIED LEFT INTRACAPSULAR RUPTURE AND POSSIBLE EXTRACAPSULAR RUPTURE ON THE RIGHT. THESE WERE CONFIRMED VIA PHYSICAL EXAMINATION BY THE PATIENT'S DOCTOR ON (B)(6) 2019. MENTOR ALSO BECAME AWARE THAT THE PATIENT WAS CAUCASIAN. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR BECAME AWARE THAT THE CORRECT DATE OF IMPLANTATION FOR THE SUSPECT MEDICAL DEVICE WAS (B)(6) 1999. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 3/26/2019, MENTOR BECAME AWARE THAT THE PATIENT ALSO EXPERIENCED RUPTURE ON THE RIGHT SIDE, DEBILITATING PAIN, ANXIETY AND NUMEROUS HEALTH ISSUES. THE RUPTURES WERE CONFIRMED BY MRI AS REPORTED. THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 2/21/2019, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE COMPLAINT DEVICE. AS A RESULT, THE MANUFACTURING DATE AND EXPIRATION DATE FIELDS HAVE BEEN UPDATED. THE MANUFACTURING RECORD EVALUATION (MRE) WAS REVIEWED, 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

    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. CONCOMITANT PRODUCTS: 500CC MENTOR MEMORYGEL BREAST IMPLANT CATALOG: 3545007, LOT: 191658. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST AUGMENTATION WITH TWO 500CC MENTOR MEMORYGEL BREAST IMPLANTS, EXPERIENCED LEFT SIDE RUPTURE POST-OPERATIVELY. RUPTURE WAS CONFIRMED BY CT-SCAN. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146688 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 191658 00081317000730

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other