BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURITAN HYDRAFLOCK STERILE FLOCKED COLLECTION DEVICE

    MDR report key: 10132678 · Received June 8, 2020

    Report

    Report Number
    MW5094886
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    April 29, 2020
    Report Date
    June 4, 2020
    Manufacturer
    PURITAN MEDICAL PRODUCTS COMPANY LLC/ MEDTRONIC INC
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NASAL SWAB BROKE OFF IN THE NARES DURING THE PROCEDURE; 25-3318-H BT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590662 PURITAN HYDRAFLOCK STERILE FLOCKED COLLECTION DEVICE APPLICATOR, ABSORBENT TIPPED, STERILE KXG PURITAN MEDICAL PRODUCTS COMPANY LLC/ MEDTRONIC INC 6736

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention