BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPRESS ULTRA 6X20MM US

    MDR report key: 12245393 · Received July 29, 2021

    Report

    Report Number
    3006345872-2021-00007
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    July 19, 2021
    Report Date
    July 29, 2021
    Manufacturer
    ENTELLUS MEDICAL, INC.
    Product Code
    PNZ
    PMA / PMN Number
    K163509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    RECEIVED PHONE CALL REPORT OF PATIENT THAT PARTICIPATED IN THE (B)(6) STUDY (EUSTACHIAN TUBE BALLOON DILATION PROCEDURE COMPLETED (B)(6) 2016) HAD PATULOUS ET THAT WAS REPAIRED BY A PHYSICIAN OUTSIDE OF THE CLINICAL TRIAL. PATIENT IS CURRENTLY SYMPTOM FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140993 XPRESS ULTRA 6X20MM US EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ ENTELLUS MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other