BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVID COLLECTION SWAB

    MDR report key: 10239051 · Received July 6, 2020

    Report

    Report Number
    MW5095375
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 20, 2020
    Report Date
    July 1, 2020
    Manufacturer
    HARDY DIAGNOSTICS
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 5CM COVID COLLECTION SWAB BROKE OFF IN LEFT NOSTRIL. SENT TO ENT FOR REMOVAL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695297 COVID COLLECTION SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG HARDY DIAGNOSTICS 20200515

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention