BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8647695 · Received May 28, 2019

    Report

    Report Number
    1645337-2019-12620
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 1, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000341
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2019, MENTOR COMPLETED MULTIPLE ATTEMPTS TO OBTAIN CLARIFICATION FOR THE PRODUCT RECEIVED (PRODUCT CODE: 3505001BC; LOT #: 7686718), HOWEVER NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, A SEARCH FOR ADDITIONAL INFORMATION IN MENTOR TRACKING DATABASE WAS DONE AND IT WAS DETECTED THAT EXPLANTED IMPLANT WAS THE LEFT SIDE. IN CONSEQUENSE, THE FOLLOWING INFORMATION HAS BEEN UPDATED: PRODUCT LOCATION: FROM "SIDE OF IMPLANT: RIGHT" TO "SIDE OF IMPLANT:LEFT" PRODUCT CODE: FROM "3505001BC" TO "3504001BC" LOT NUMBER: FROM "7319923" TO "7686718" SERIAL NUMBER: FROM (B)(4). DATE OF EXPLANT: FROM "BLANK" TO "(B)(6) 2019" CONCOMITANT PRODUCT: FROM "BLANK" TO "R) CODE: 3505001BC; SN: (B)(4). ASSOCIATED PRODUCTS: FROM "BLANK" TO "L) CODE: 3505001BC; SN: (B)(4). 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. ON (B)(6) 2019, DEVICE EVALUATION WAS COMPLETED. DEVICE EVALUATION SUMMARY: DURING VISUAL INSPECTION OF THE DEVICE IT WAS OBSERVED WITH NO APPARENT DAMAGE. NO ANOMALIES WERE OBSERVED. POSTOPERATIVE FORMATION OF A FIBROUS TISSUE CAPSULE AROUND A MAMMARY PROSTHESIS IS A NORMAL PHYSIOLOGIC RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT AND OCCURS IN ALL PATIENTS IN VARYING DEGREES. IN SOME CASES, CONTRACTURE OF THE FIBROUS CAPSULE MAY OCCUR. THIS PHENOMENON IS REFERRED TO AS CAPSULAR CONTRACTURE. AN INVESTIGATION OF THE RETURNED DEVICE WAS PERFORMED, AND MENTOR COULD NOT UNCOVER ANY DEVICE FAILURE THAT COULD BE CONNECTED TO THE REPORTED MEDICAL SYMPTOMS. 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: AS OF NOW THERE IS NO INFORMATION REGARDING THE EXPLANT OR REOPERATION. CONCOMITANT PRODUCTS: LEFT SIDE 400CC MENTOR MEMORYGEL BREAST IMPLANT; CAT#: 3504001BC; S/N: (B)(4). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH 500CC MENTOR MEMORYGEL BREAST IMPLANT AND WAS PRESENTED WITH RIGHT SIDE CAPSULAR CONTRACTURE; BAKER GRADE UNKNOWN. 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
    438720 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 7686718 00081317000341

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other