BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX ROUND MODERATE PROFILE

    MDR report key: 16074861 · Received December 29, 2022

    Report

    Report Number
    1645337-2022-15669
    Event Type
    Injury
    Date Received
    December 29, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001799
    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 JANUARY 11, 2023, MENTOR COMPLETED A MANUFACTURING RECORD EVALUATION (MRE) FOR THE PROVIDED LOT NUMBER, 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. ADDITIONALLY, THE MANUFACTURING RECORD EVALUATION VERIFIED THE DEVICE MANUFACTURING DATE AND DEVICE EXPIRATION DATE OF THE IMPACTED DEVICE. EXPIRATION DATE: JULY 01, 1995. MANUFACTURE DATE: JULY 31, 2003. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    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.A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.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.REASON FOR DEVICE EXPLANT AND/OR REOPERATION:DEFLATION.MANUFACTURER¿S REFERENCE NUMBER:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH 325CC MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST IMPLANTS. POST-OPERATIVELY, THE PATIENT EXPERIENCED BILATERAL DEFLATION, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH 500CC MENTOR MEMORYGEL BREAST IMPLANTS ON (B)(6) 2009. THIS REPORT IS FOR THE RIGHT IMPLANT. REFER TO MANUFACTURING REPORT NUMBER 1645337-2022-15670 FOR THE CONTRALATERAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409648 MENTOR SILTEX ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542650 123891 00081317001799

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention