BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9615633 · Received January 22, 2020

    Report

    Report Number
    1645337-2020-01110
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    December 23, 2019
    Report Date
    January 2, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000259
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, 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 5/27/2020, IT WAS REPORTED TO MENTOR THAT THE DATE OF REMOVAL WILL BE (B)(6) 2020. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: RUPTURE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, IT WAS REPORTED TO MENTOR THAT THE REPLACEMENT DEVICES WERE MENTOR MEMORYGEL BREAST IMPLANT 300CC ON (B)(6) 2020, DURING THE VISUAL INSPECTION, THE DEVICE WAS FOUND TO BE RUPTURED, IT WAS RECEIVED IN FOUR PIECES. MICROSCOPIC EXAMINATION IN THE TEAR EDGES REVEALED PARALLEL STRIATIONS THAT ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. A SECOND PRODUCT WAS RECEIVED (PRODUCT CODE 3502251BC AND LOT NUMBER 6834442). NO ADVERSE EVENTS WERE REPORTED FOR THIS CONCOMITANT (CONTRALATERAL) DEVICE, THEREFORE NO FURTHER ANALYSIS IS REQUIRED. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. RUPTURE COMPLAINT INFORMATION IS CONSISTENTLY ANALYZED AND MONITORED BY MENTOR QUALITY ASSURANCE TO DETERMINE WHEN FURTHER ACTION IS NECESSARY. MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 1/24/2020, 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

    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 MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. CONCOMITANT MEDICAL PRODUCTS: A MENTOR MEMORYGEL BREAST IMPLANT 225CC, CATALOG NUMBER 3502251BC, SERIAL NUMBER (B)(4), LOT NUMBER 6834442. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR MEMORYGEL BREAST IMPLANT 225CC AND EXPERIENCED SYMPTOMATIC RUPTURE ON THE RIGHT BREAST IMPLANT. RIGHT BREAST FELT SOFTER, THE PATIENT EXPERIENCED ASYMMETRY DUE TO RUPTURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THE PATIENT IS PLANNING TO EXPLANT THE IMPLANT IN THE FUTURE AT SOME POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78098 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3502251BC 6845449 00081317000259

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other