BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 7912289 · Received September 26, 2018

    Report

    Report Number
    1645337-2018-05776
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    September 4, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000136
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/01/2019, 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. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 1/10/2019, MENTOR BECAME AWARE OF NEW UPDATES WHICH ARE: DATE OF EVENT UPDATED TO (B)(6) 2018, AS A RESULT PATIENT AGE CHANGES TO 49 YEARS OLD AT THE TIME OF EVENT. PATIENT UNDERWENT BILATERAL REMOVAL AND REPLACEMENT AS FOLLOW: RIGHT REPLACED WITH CATALOG NUMBER 3507255MC, SERIAL NUMBER (B)(4), AND LEFT WAS REPLACED WITH CATALOG NUMBER 3507275MC, SERIAL NUMBER (B)(4) ON (B)(6) 2018 . THIS REPORT IS FOR THE LEFT IMPLANT. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE DEVICE WAS RECEIVED WITH CLEAR GEL. BROWN AND YELLOW MATERIALS WERE OBSERVED WITHIN THE DEVICE, BROWN, BLACK, YELLOW MATERIALS AND GEL WAS OBSERVED ON THE SHELL SURFACE. DURING EVALUATION THE DEVICE APPEARED INTACT. NO ANOMALIES WERE DISCOVERED. MENTOR PRODUCTS ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE IN ADDITION TO THOROUGH IN-PROCESS TESTING DURING SEVERAL STAGES OF THE MANUFACTURING PROCESS. SINCE THIS INVESTIGATION IS RELATED ONLY TO AN ADVERSE EVENT, IS NOT POSSIBLE TO ADDRESS ANY FAILURE OR DAMAGE OF THE DEVICE TO A PATIENT INJURY. A SKIN REACTION IS A NOTICEABLE CHANGE IN THE TEXTURE AND/ OR COLOR OF THE SKIN. THIS CAN INCLUDE BUMPS, SCALES, PUSTULES OR REDNESS THAT CAN BE INFLAMED, IRRITATED, PAINFUL, OR ITCHY. THIS CAN BE DUE TO A VARIETY OF FACTORS SUCH AS INFECTIONS, HEAT, ALLERGENS OR IMMUNE SYSTEM DISORDERS. ALL THE IMPLANTS ARE 100% INSPECTED BEFORE LEAVING THE FACILITY. THERE IS NO EVIDENCE THAT THE ISSUE IS RELATED WITH MANUFACTURING 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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT MEDICAL PRODUCTS: RIGHT MENTOR MEMORYGEL, GEL MOD-RND 400CC BREAST IMPLANT, CATALOG NUMBER 3507400BC, LOT NUMBER 231595. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT ENROLLED IN A CLINICAL STUDY WHO UNDERWENT BREAST AUGMENTATION REVISION ON (B)(6) 2002 EXPERIENCED BILATERAL REDNESS OF HER BREASTS. THE PATIENT ALSO NOTED THAT HER RIGHT BREAST SIZE CHANGED AND HER IMPLANT WAS PUSHING UP. SHE WAS DIAGNOSED WITH RIGHT SIDE BAKER GRADE UNKNOWN CAPSULAR CONTRACTURE AND RIGHT SIDE DEVICE RUPTURE CONFIRMED BY MAMMOGRAM IN 2017. THE PATIENT'S DEVICES ARE STILL IMPLANTED AND NO DATE OF REVISION OR EXPLANTATION WAS REPORTED. THIS REPORT IS FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750293 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 225916 00081317000136

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R