BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SAMPLING SWAB

    MDR report key: 11462023 · Received March 10, 2021

    Report

    Report Number
    MW5099907
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 8, 2021
    Manufacturer
    MIRACLEAN TECHNOLOGY CO. LTD
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    [DISPOSABLE SAMPLING SWAB FOR SARS-COV-2 TESTING] TREATMENT UNDER EMERGENCY USE AUTHORIZATION (EUA): DISPOSABLE SAMPLING SWAB (NASOPHARYNGEAL) TO OBTAIN SPECIMEN FOR SARS-COV-2 BROKE DURING SPECIMEN COLLECTION, LEAVING APPROXIMATELY 4CM OF SWAB IN PATIENT NASOPHARYNX. OBJECT RETRIEVED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346650 DISPOSABLE SAMPLING SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG MIRACLEAN TECHNOLOGY CO. LTD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR