BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS

    MDR report key: 24167706 · Received January 23, 2026

    Report

    Report Number
    1645337-2026-00790
    Event Type
    Injury
    Date Received
    January 23, 2026
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURING RECORD EVALUATION (MRE) WAS ATTEMPTED ON REPORT LOT NUMBER 993970, BUT MENTOR COULD NOT CONFIRM THE LOT NUMBER. AS A RESULT, THE MRE COULD NOT BE COMPLETED. 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 FOR LOT #993970 REPORTED FOR PATIENT'S LEFT BREAST IMPLANT. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PROSTHESIS DEFLATION. D4: UDI: (01) GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE. 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 PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR SILTEX ROUND MODERATE PROFILE SALINE BREAST PROSTHESIS (LEFT IMPLANT) AND AN UNSPECIFIED MENTOR SALINE BREAST PROSTHESIS (RIGHT IMPLANT) WHEN THE PATIENT SUFFERED BREAST PROSTHESIS DEFLATION. THE SIDE OF DEFLATION (LEFT BREAST, RIGHT BREAST, OR BILATERAL) WAS NOT SPECIFIED. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED MENTOR SALINE BREAST PROSTHESES. INFORMATION ABOUT TWO DEVICES WAS REPORTED: LEFT IMPLANT: CATALOG #3542640, LOT #993970. RIGHT IMPLANT: UNKNOWN CATALOG NUMBER AND UNKNOWN LOT NUMBER. IF CLARIFICATION IS RECEIVED REGARDING WHICH DEVICE DEFLATED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224910 UNKNOWN SALINE IMPLANTS PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 993970

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention