BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SAMPLING SWAB

    MDR report key: 10055587 · Received May 13, 2020

    Report

    Report Number
    MW5094478
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    May 12, 2020
    Report Date
    May 12, 2020
    Manufacturer
    UNK
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF SWAB BROKE OFF IN PT'S THROAT AND HE ALMOST INHALED IT. PT WAS TOO WEAK TO COUGH IT OUT. ED PHYSICIAN ABLE TO GET IT OUT WITH TONGUE DEPRESSOR. ALMOST REQUIRED INTUBATION OR TRACHEOSTOMY. ON (B)(6) 2020 COVID 19 THROAT SWAB. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518013 DISPOSABLE SAMPLING SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention