BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGENE® HC2 DNA COLLECTION DEVICE

    MDR report key: 16157358 · Received January 13, 2023

    Report

    Report Number
    1122376-2023-00001
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    November 21, 2022
    Report Date
    January 13, 2023
    Manufacturer
    QIAGEN SCIENCES, LLC
    Product Code
    HHT
    PMA / PMN Number
    K971586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCE SYNCOPE DURING COLLECTION PROCEDURE AND WAS TREATED BY THE ATTENDING PHYSICIAN. PATIENT WAS DISCHARGED AND REPORTED NO DISCOMFORT. PHYSICIAN REPORTED THE MOST LIKELY CAUSE FOR PATIENT FAINTING WAS PATIENT NOT HAVING BREAKFAST AS WELL AS BEING NERVOUS. THERE WAS NO REPORT OF DEVICE MALFUNCTION OR DEFECT FROM THE FACILITY.

    Description of Event or Problem · 0

    PATIENT FAINTED DURING SAMPLING PROCEDURE WITH HC2 DNA COLLECTION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963370 DIGENE® HC2 DNA COLLECTION DEVICE SPATULA, CERVICAL, CYTOLOGICAL HHT QIAGEN SCIENCES, LLC M2309

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other