BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 16390359 · Received February 16, 2023

    Report

    Report Number
    1645337-2023-01839
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    February 1, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001782
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 28, 2023, MENTOR 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. ON MARCH 15, 2023, MENTOR BECAME AWARE THAT INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. THE LOT NUMBER OF THE IMPACTED DEVICE WAS PROVIDED AS 124844. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4) IN THE INITIAL REPORT, D4. LOT NUMBER SHOULD HAVE BEEN POPULATED WITH 124844. D4. EXPIRATION DATE SHOULD HAVE BEEN POPULATED WITH 8/31/2003 D6A. SHOULD HAVE BEEN POPULATED WITH SEPTEMBER 01, 1995. H4. DEVICE MANUFACTURE DATE SHOULD HAVE BEEN POPULATED WITH 8/1/1995.

    Additional Manufacturer Narrative · 0

    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. 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. ADVERSE EVENT HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: DEFLATION, GENERALIZED ILLNESS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON APRIL 16, 2023, MENTOR COMPLETED A VISUAL INSPECTION AND LEAK TESTING OF THE RETURNED DEVICE. DEVICE EVALUATION SUMMARY: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE BREAST IMPLANT. LEAK TESTING WAS PERFORMED, IN ACCORDANCE WITH MENTOR PROCEDURES, AND NO LEAK SITES WERE DETECTED DURING THE ANALYSIS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE BREAST IMPLANT WAS RETURNED WITHOUT DETECTABLE DAMAGE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. AT THE PRESENT TIME, THERE IS NO SUFFICIENT EVIDENCE TO SHOW AN ASSOCIATION BETWEEN BREAST IMPLANTS AND GENERALIZED ILLNESS (ASSESSING THE RISKS OF BREAST IMPLANTS AND FDA¿S VISION FOR THE NATIONAL BREAST IMPLANT REGISTRY). MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 70-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION SURGERY WITH 300CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT HAD A MAMMOGRAM. AFTER THE EXAM, THE PATIENT EXPERIENCED BILATERAL DEFLATION OF BOTH PROSTHESES, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. THE PATIENT ALSO REPORTED EXPERIENCING WEIGHT LOSS. AS A RESULT, THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2023. THIS REPORT IS FOR THE LEFT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-14946 FOR THE CONTRALATERAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373221 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542645 124844 00081317001782

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention