BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 8884147 · Received August 12, 2019

    Report

    Report Number
    1645337-2019-16840
    Event Type
    Injury
    Date Received
    August 12, 2019
    Date of Event
    April 24, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MENTOR MEDICAL SYSTEM B.V.
    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

    DEVICE EVALUATION SUMMARY: DURING VISUAL INSPECTION OF THE DEVICE IT WAS OBSERVED WITH NO APPARENT DAMAGE. LEAK TESTING WAS PERFORMED IN ACCORDANCE WITH MENTOR PROCEDURES AND NO LEAK SITES WERE DETECTED. NO ANOMALIES WERE OBSERVED. GRANULOMAS ARE NONCANCEROUS NODULES THAT ARE A COMMON TISSUE REACTION TO THE PRESENCE OF A VARIETY OF FOREIGN MATERIALS, SUCH AS SILICONE. THE MANUFACTURING RECORDS WERE REVIEWED, AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. AN INVESTIGATION OF THE RETURNED DEVICE WAS PERFORMED, AND MENTOR COULD NOT UNCOVER ANY DEVICE FAILURE THAT WE COULD CONNECT TO THE REPORTED MEDICAL SYMPTOMS. 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE REPORTED IN THIS COMPLAINT WAS MANUFACTURED IN FRANCE. THE PEROUSE BREAST IMPLANTS THAT ARE MANUFACTURED AND DISTRIBUTED UNDER THE MENTOR BRAND BUT ARE NOT APPROVED FOR IMPORT INTO THE UNITED STATES DO NOT MEET THE CRITERIA FOR MDR REPORTING AS A SAME OR SIMILAR DEVICE TO A DEVICE THAT IS MARKETED IN THE UNITED STATES. SPECIFICALLY, THE DEVICES DIFFER IN MANUFACTURING PROCESSES AND DEVICE SPECIFICATIONS. THEREFORE, EVENTS THAT INVOLVE THESE DEVICES WOULD NOT NEED TO BE REPORTED AS ASRS/PSRS OR MDRS. PHONE NUMBER: (B)(6). MANUFACTURING SITE PHONE NUMBER: (B)(6). MANUFACTURER¿S REFERENCE NUMBER: (B)(6). (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10/01/2019, 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. THE INFORMATION OF THE SUSPECT DEVICE IS AS FOLLOW:CA T#:3544375, LOT#:: 6572475. CONCOMITANT PRODUCT: MENTOR MEMORYGEL BREAST IMPLANT, 375CC, CAT#:3544375, LOT#:3544375 THE NEW INFORMATION RECEIVED INDICATED THAT PATIENT ALSO HAD ISSUE WITH GEL LEAK ON THE RIGHT SIDE.. PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: LEFT REPLACED WITH CAT#:3504254BC, SERIAL NUMBER (B)(6). AND RIGHT REPLACED WITH CAT#:3504254BC, SERIAL NUMBER (B)(6). A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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: CONCOMITANT PRODUCTS: UNKNOWN RIGHT DEVICE. 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 PRIMARY BREAST AUGMENTATION WITH UNKNOWN SILICONE BREAST IMPLANTS WHICH THE LEFT SIDE RUPTURED WITH THE ISSUE OF GRANULOMA AFTER IMPLANTATION. THE ISSUE OF EXTRACAPSULAR RUPTURE CONFIRMED BY MRI EXAMINATIONS, AND WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH ANOTHER MENTOR GEL (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676607 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR MEDICAL SYSTEM B.V. 6572475

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention