BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TISSUE EXPANDERS

    MDR report key: 20452394 · Received October 15, 2024

    Report

    Report Number
    1645337-2024-12040
    Event Type
    Injury
    Date Received
    October 15, 2024
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: MULTIPLE ADVERSE EVENTS REPORTED. REFER TO BLOCK B5 FOR REASONS FOR DEVICE EXPLANT AND/OR REOPERATION. H6 HEALTH EFFECT - CLINICAL CODE E2402: GENERALIZED ILLNESS, PATIENT DISSATISFACTION WITH PROCEDURE OUTCOME. D1 INITIAL REPORTER PHONE: (B)(6). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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), THE DATA FROM THE DUTCH BREAST IMPLANT REGISTRY (DBIR). IT WAS ALSO FOUND IN A LITERATURE SOURCE. TITLE: RISK FACTORS FOR UNPLANNED REOPERATION DURING THE EXPANSION PHASE IN TWO-STAGE BREAST RECONSTRUCTION IN THE DUTCH BREAST IMPLANT REGISTRY. THE STUDY AIMED TO IDENTIFY RISK FACTORS FOR UNPLANNED REOPERATION AFTER TISSUE EXPANDER PLACEMENT, ASSESSED THE TIME UNTIL UNPLANNED AND PLANNED REOPERATION, AND INVESTIGATED INDICATIONS FOR UNPLANNED REOPERATION. PATIENT AND SURGERY-RELATED CHARACTERISTICS OF PATIENTS WHO UNDERWENT TWO-STAGE POSTMASTECTOMY BREAST RECONSTRUCTIONS (PMBR) BETWEEN 2017 AND 2021 WERE COLLECTED FROM THE DUTCH BREAST IMPLANT REGISTRY (DBIR). UNPLANNED REOPERATION WAS DEFINED AS TE EXPLANTATION FOLLOWED BY EITHER NO REPLACEMENT OR REPLACEMENT WITH THE SAME OR A DIFFERENT TE. CO-VARIATE ADJUSTED CHARACTERISTICS ASSOCIATED WITH UNPLANNED REOPERATION WERE DETERMINED USING BACKWARD STEPWISE SELECTION AND MULTIVARIABLE LOGISTIC REGRESSION ANALYSES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE ADVERSE EVENT(S) QTY UNK-DEEP WOUND INFECTION QTY UNK-SEROMA QTY UNK-HEMATOMA QTY UNK-SKIN NECROSIS QTY UNK-DEHISCENCE QTY UNK-BREAST PAIN QTY 28 - DEVICE DEFLATION QTY UNK-CAPSULAR CONTRACTURE QTY UNK -ASYMMETRY QTY UNK -DEVICE MALPOSITION QTY UNK -PATIENT DISSATISFIED QTY UNK - BREAST CANCER RECURRENCE QTY UNK - BREAST IMPLANT-ASSOCIATED ILLNESS QTY UNK - DEVICE REMOVAL QTY UNK - SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36076 UNKNOWN TISSUE EXPANDERS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention