BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 15621436 · Received October 18, 2022

    Report

    Report Number
    1645337-2022-11687
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    April 16, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    UDI-DI
    00081317000488
    PMA / PMN Number
    P030053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS PART OF A BATCH OF LATE REPORTS RESULTING FROM INTERNALLY IDENTIFIED DATA INCONSISTENCIES BETWEEN A POSTMARKET STUDY AND OUR COMPLAINT HANDLING DATABASES. 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. 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: GENERALIZED ILLNESS. (B)(4). DATE OF BIRTH: 1988. 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 MARCH 28, 2023, MENTOR RECEIVED ADDITIONAL INFORMATION REGARDING THE PATIENT'S COMPLAINT. IT WAS REPORTED THAT THE PATIENT ALSO REPORTED DISSATISFACTION WITH THE PROCEDURAL OUTCOME. MANUFACTURER¿S REFERENCE NUMBER: (B)(4)

    Additional Manufacturer Narrative · 0

    ON APRIL 17, 2024, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT UNDERWENT DEVICE EXPLANTATION ON (B)(6), 2021. THE EXPLANTATION DATE IN SECTION D6B. HAS BEEN UPDATED TO (B)(6), 2021 TO CAPTURE THIS ADDITIONAL INFORMATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS EVENT IS ASSOCIATED WITH THE GLOW CLINICAL TRIAL (SUBJECT ID: 875-038) IT WAS REPORTED THAT A HISPANIC FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH TWO 350CC MENTOR MEMORYGEL BREAST IMPLANTS AND EXPERIENCED SEVERAL POST-OP RHEUMATOLOGY SIGNS AND GENERALIZED ILLNESS SYMPTOMS INCLUDING JOINT STIFFNESS, JOINT PAIN, JOINT SWELLING, AND SKIN RASHES POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2022. THIS REPORT IS FOR THE LEFT SIDE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391506 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS 3503504BC 7566501 00081317000488

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention