BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR CE MED HGT TE W/SUT TABS 650CC

    MDR report key: 22985399 · Received September 5, 2025

    Report

    Report Number
    1645337-2025-09857
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    April 2, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 09-OCT-2025, A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED ON LOT #9990821 AND LOT # 9808682, 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).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS BEEN DISCARDED. AS A RESULT, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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: INFECTION, PAIN, PATIENT WAS UNHAPPY. 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 05-SEP-2025, MENTOR RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT. TWO LOT NUMBERS AND TWO SERIAL NUMBERS WERE REPORTED: DEVICE #1: LOT #9990821, SERIAL # (B)(6). DEVICE #2: LOT #9808682, SERIAL # (B)(6). IT WAS NOT SPECIFIED WHICH OF THESE CORRESPONDS TO THE PATIENT¿S RIGHT BREAST TISSUE EXPANDER THAT WAS IMPLANTED ON 2025 AND EXPLANTED ON (B)(6) 2025. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. A MANUFACTURING RECORD EVALUATION IS IN PROGRESS. ONCE COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CE MED HGT TE W/SUT TABS 650CC TISSUE EXPANDER DEVELOPED PAIN AND INFECTION IN HER RIGHT BREAST POST IMPLANTATION. THE PATIENT WAS UNHAPPY WITH THE RESULTS. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE WAS ¿PUNCTURED¿. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR CE MED HGT TE W/SUT TABS 650CC TISSUE EXPANDER ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264102 MENTOR CE MED HGT TE W/SUT TABS 650CC EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS 9990821, 9808682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention