BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING

    MDR report key: 10918516 · Received November 25, 2020

    Report

    Report Number
    MW5098105
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 20, 2020
    Report Date
    November 23, 2020
    Manufacturer
    SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    Product Code
    KXG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING COVID TESTING USING NASAL SWAB- STICK BREAKAGE AT POINT #2 AND/OR#3 IN ATTACHED PHOTO DURING SWABBING/TESTING AND TIP OF SWAB LODGED IN PATIENT'S NASAL CAVITY. THIS HAS BEEN PREVIOUSLY REPORTED IN OUR HEALTH SYSTEM ON AT LEAST 9 DIFFERENT OCCASIONS. IDENTIFYING INFORMATION PROVIDED PRIOR TO THE LATEST PHOTO WHICH SPECIFIES MANUFACTURER: MANUFACTURER NAME: MANUFACTURED IN (B)(4) AND OBTAINED VIA MULTIPLE DISTRIBUTERS LOT AND DATE INFORMATION: LOT 20200530, MFG 20200530, EXP 20210529. COVID TESTING USING NASAL SWABS WITH BREAKAGE OCCURRED IN (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364340 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD 2020-08-24
    1364341 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    1364342 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    1364343 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    1364344 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    1364345 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    1364346 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    1364347 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD
    1364348 SAMPLING COLLECTOR - COVID-19 NASAL SWAB FOR TESTING APPLICATOR, ABSORBENT TIPPED, STERILE KXG SUZHOU CELLPRO BIOTECHNOLOGY CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other