BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 10479930 · Received September 1, 2020

    Report

    Report Number
    1645337-2020-10894
    Event Type
    Injury
    Date Received
    September 1, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 12, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 2-SEP-2020, THE SUSPECTED MEDICAL DEVICE WAS RETURNED FOR EVALUATION. MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE SUSPECTED MEDICAL DEVICE. THE DEVICE IS A 500CC MENTOR MEMORYGEL BREAST IMPLANT (CATALOG #: 3505001BC, LOT #: 6981800). THE RELEVANT FIELDS HAVE BEEN UPDATED. ON 21-SEP-2020, THE INVESTIGATION ON THE SUSPECTED MEDICAL DEVICE WAS COMPLETED. INVESTIGATION SUMMARY: DURING VISUAL EVALUATION OF THE DEVICE, IT WAS OBSERVED TO BE RUPTURED. RUPTURE CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT IT IS MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. TRAUMA IS A KNOWN INHERENT RISK OF GEL-FILLED MAMMARY PROSTHESIS. MENTOR DID NOT RECEIVE PERMISSION TO PERFORM DESTRUCTIVE TESTING.  AS A RESULT, THE ANALYSIS FROM THE PRODUCT EVALUATION LAB WAS LIMITED TO NON-DESTRUCTIVE TESTING, AND WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE RUPTURE. 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. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE SIDE OF THE IMPLANT. THE DEVICE WAS IMPLANTED IN THE PATIENT'S LEFT BREAST. 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: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A REVISION BREAST AUGMENTATION WITH AN UNSPECIFIED MENTOR GEL BREAST IMPLANT AND EXPERIENCED POSTOPERATIVE RUPTURE (SIDE UNKNOWN). THE PATIENT WAS INVOLVED IN AN AUTOMOBILE ACCIDENT, AND THE DIAGNOSIS WAS CONFIRMED VIA A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT WITH TWO 605CC MENTOR MEMORYGEL BREAST IMPLANT PROSTHESES (CATALOG #: SMPX605, LEFT SERIAL #:(B)(4), RIGHT SERIAL #: (B)(4) ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940417 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 6981800

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention