BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLOGIC

    MDR report key: 4884058 · Received June 16, 2015

    Report

    Report Number
    MW5043412
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Manufacturer
    HOLOGIC
    Product Code
    HHS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED NOVA SURE ENDOMETRIAL ABLATION. PT WILL HAVE TO COME BACK TO TRY AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390103 HOLOGIC NOVA - SURE ESSURE HHS HOLOGIC NS2200US 15CI3RB

    Patients

    Seq Age Sex Outcome Treatment
    1