BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 9999527 · Received April 26, 2020

    Report

    Report Number
    1645337-2020-05859
    Event Type
    Injury
    Date Received
    April 26, 2020
    Date of Event
    February 27, 2020
    Report Date
    April 1, 2020
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317006992
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ON (B)(6) 2020, MENTOR BECAME AWARE OF THE CORRECT EXPLANTATION DATE. ON (B)(6) 2020, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE INVESTIGATION SUMMARY: DURING VISUAL EVALUATION NO APPARENT DAMAGE OR VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS 7713333 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 19, 20224, MENTOR BECAME AWARE THAT THE DATE OF SURGERY WAS (B)(6) 2020. FIELD D6B HAVE BEEN UPDATED ACCORDINGLY. THIS SUPPLEMENTAL REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. 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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: ANISOMATIA. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) CAUCASIAN FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH 535CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED BAKER GRADE III CAPSULAR CONTRACTURE ON THE LEFT SIDE AND ANISOMASTIA ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT BILATERAL DEVICE REMOVAL ON( B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463010 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3505590BC 7713333 00081317006992

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention