BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TISSUE EXPANDERS

    MDR report key: 13722924 · Received March 10, 2022

    Report

    Report Number
    1645337-2022-02615
    Event Type
    Injury
    Date Received
    March 10, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    LCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: DEEP WOUND INFECTION, CAPSULAR CONTRACTURE, DEVICE RUPTURE/DEFLATION, SEROMA/HAEMATOMA, DEVICE MALPOSITION, SKIN SCARRING PROBLEMS, AND BREAST CANCER. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: CPX4 MENTOR TISSUE EXPANDER. THIS REPORT CAPTURES THE TOTAL REVISIONS FOR 2016-2020 ASSOCIATED WITH THIS DRRA. A TOTAL OF 232 TISSUE EXPANDERS WERE REVISED IN 2016-2020. 135 WERE REPLACEMENT REVISION, 6 WERE REPOSITION AND 91 WERE EXPLANT ONLY. 111 REVISIONS OCCURRED POST-CANCER AND 54 REVISIONS OCCURRED AS RISK-REDUCING. ADVERSE EVENT(S) REPORTED FOR CPX4 MENTOR TISSUE EXPANDERS USED FOR BREAST RECONSTRUCTIVE PROCEDURES ASSOCIATED WITH REVISIONS IN 2016-2020: QTY 75 DEEP WOUND INFECTION ,QTY 15 CAPSULAR CONTRACTURE ,QTY 40 DEVICE RUPTURE/DEFLATION ,QTY 44 SEROMA/HAEMATOMA ,QTY 9 DEVICE MALPOSITION ,QTY 12 SKIN SCARRING PROBLEMS , AND QTY 4 BREAST CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270167 UNKNOWN TISSUE EXPANDERS EXPANDER, SKIN, INFLATABLE LCJ MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R