BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TISSUE EXPANDERS

    MDR report key: 22374745 · Received July 1, 2025

    Report

    Report Number
    1645337-2025-07192
    Event Type
    Injury
    Date Received
    July 1, 2025
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, BREAST PAIN, ANISOMASTIA, PATIENT DISSATISFACTION WITH PROCEDURAL OUTCOME, BREAST CANCER, SEROMA, IMPAIRED HEALING, WOUND INFECTION, DEFLATION, DEVICE MIGRATION. D4: UDI: AS THE DEVICE INFORMATION WAS NOT PROVIDED, THE UDI IS NOT AVAILABLE. H6 HEALTH EFFECT - CLINICAL CODE E2402: PATIENT DISSATISFACTION WITH PROCEDURE OUTCOME. 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

    THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA). DUTCH BREAST IMPLANT REGISTRY (DBIR). DBIR IS A NATIONAL, PROSPECTIVE, OPT-OUT REGISTRY, WITH MANDATORY REGISTRATION FOR ALL PLASTIC SURGEONS IN THE NETHERLANDS WHO ARE MEMBER OF THE NETHERLANDS SOCIETY OF PLASTIC SURGERY (NVPC). OBJECT OF THE REPORT IS COMPARING QUARTERLY MENTOR WORLDWIDE, LLC DATA WITH DATA FROM THE NATIONAL BREAST IMPLANT REGISTRY (NBIR). COMPLICATIONS AND PERIOPERATIVE FINDINGS, RECONSTRUCTIVE TISSUE EXPANDERS MENTIONED IN THE REPORT (2023). 1. CAPSULAR CONTRACTURE ¿ 26 2. BREAST PAIN 20 3. DEVICE RUPTURE/DEFLATION 29 4. ASYMMETRY 18 5. DISSATISFACTION 10 6. DEVICE MALPOSITION 11 7. BREAST CANCER 10 8. SEROMA/HEMATOMA 25 9. SKIN NECROSIS OR DEHISCENCE 28 10. WOUND INFECTION 54.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357706 UNKNOWN TISSUE EXPANDERS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Life Threatening| R