BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8932062 · Received August 26, 2019

    Report

    Report Number
    1645337-2019-17829
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 5, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000549
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 8/27/2019, THE MENTOR FAILURE ANALYSIS LAB HAS RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETE AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 5781827, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10/01/2019, DURING EVALUATION OF THE DEVICE IT WAS OBSERVED TO BE RUPTURED. DURING THE MICROSCOPE EXAMINATION STRIATIONS WERE DETECTED IN THE EDGES OF THE RUPTURE. NO OTHER ANOMALIES WERE DISCOVERED. THE STRIATIONS ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. AS STATED IN THE PRODUCT INSERT DATA SHEET, DO NOT ALLOW CAUTERY DEVICES OR SHARP INSTRUMENTS, SUCH AS SCALPELS, SUTURE NEEDLES, HYPODERMIC NEEDLES, HEMOSTATS, ADSON FORCEPS OR SCISSORS TO CONTACT THE DEVICE DURING THE IMPLANTATION OR OTHER SURGICAL PROCEDURES AS THIS CAN RESULT IN RUPTURE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. RUPTURE, AS INDICATED IN THE PRODUCT INSERT DATA SHEET (PIDS), IS A KNOWN COMPLICATION ASSOCIATED WITH MENTOR MAMMARY PROSTHESES. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED AND MONITOR BY QUALITY ASSURANCE ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY. 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: RUPTURE. CONCOMITANT MEDICAL PRODUCTS: MENTOR MEMORYGEL BREAST IMPLANT 550CC, CATALOG 3505004BC, SERIAL NUMBER (B)(4), LOT 5797604. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 550CC AND EXPERIENCED RUPTURE ON THE RIGHT IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725122 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 5781827 00081317000549

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention