BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE

    MDR report key: 9450715 · Received December 11, 2019

    Report

    Report Number
    9450715
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    October 12, 2019
    Report Date
    December 2, 2019
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HAND PIECE WOULDN'T MEASURE, KEPT BEEPING. MANUFACTURER RESPONSE FOR NOVASURE, HOLOGIC, INC. (PER SITE REPORTER): THEY WILL INITIATE AN INVESTIGATION AND REIMBURSE US FOR THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247877 NOVASURE DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB HOLOGIC, INC. 2000 19G29R

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA