BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILATOR, UTERINE, HANK, D/E, 15/16 FR

    MDR report key: 23032876 · Received September 11, 2025

    Report

    Report Number
    1417592-2025-00467
    Event Type
    Injury
    Date Received
    September 11, 2025
    Date of Event
    August 13, 2025
    Report Date
    September 11, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    HDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY, ON (B)(6) 2025, "DURING A PROCEDURE, A HANK DILATOR FROM JARIT HANK DILATOR 15/16 FR SIZE WAS BEING USED. THEY OPENED AN ANOTHER SET WHICH HAD THE MEDLINE HANK DILATOR 15/16 FR SIZE TO USE AND TORE THE CERVIX DUE TO THE SIZING NOT MATCHING TO THE OTHER." NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY, ON (B)(6) 2025, "DURING A PROCEDURE, A HANK DILATOR FROM JARIT HANK DILATOR 15/16 FR SIZE WAS BEING USED. THEY OPENED ANOTHER SET WHICH HAD THE MEDLINE HANK DILATOR 15/16 FR SIZE TO USE AND TORE THE CERVIX DUE TO THE SIZING NOT MATCHING TO THE OTHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365885 DILATOR, UTERINE, HANK, D/E, 15/16 FR HDQ MEDLINE INDUSTRIES, LP (10) 31073806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other