BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAB SAMPLING 12 CM DISPOSABLE

    MDR report key: 10108669 · Received June 1, 2020

    Report

    Report Number
    MW5094772
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 19, 2020
    Report Date
    May 29, 2020
    Manufacturer
    UNK
    Product Code
    KXF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE COTTON TIP BROKE OFF THE DISPOSABLE SAMPLING SWAB. THE HEALTH CARE TEAM BELIEF THE PATIENT SWALLOWED THE COTTON TIP WITH NO TREATMENT REQUIRED. RESOURCE OPTIMIZATION & INNOVATION; PATIENT WAS BEING TESTED FOR COVID-19 WITH SWAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568562 SWAB SAMPLING 12 CM DISPOSABLE APPLICATOR, ABSORBENT TIPPED, NON-STERILE KXF UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other