BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 17726299 · Received September 11, 2023

    Report

    Report Number
    1645337-2023-10687
    Event Type
    Injury
    Date Received
    September 11, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 173571 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: APR/1998. EXPIRATION DATE: APR/2006 . A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 173341 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. MANUFACTURING DATE: APR/1998. EXPIRATION DATE: APR/2006. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: N/A. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A (LEFT) 325CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE AND A (RIGHT) 425CC MENTOR SMOOTH ROUND MODERATE PROFILE SALINE BREAST PROSTHESES. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT RUPTURE ON AN UNSPECIFIED BREAST. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SINCE IT WAS NOT SPECIFIED WHICH BREAST IMPLANT RUPTURED, BOTH THE LEFT AND RIGHT BREAST IMPLANT INFORMATION WILL BE PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE CLARIFYING INFORMATION IS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634047 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 173571/ 173341

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other