BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELISWAB COVID-19 RAPID TEST

    MDR report key: 15968827 · Received December 13, 2022

    Report

    Report Number
    3004142665-2022-00043
    Event Type
    Injury
    Date Received
    December 13, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 13, 2022
    Manufacturer
    ORASURE TECHNOLOGIES, INC
    Product Code
    QKP
    PMA / PMN Number
    EUA210378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6)2022, CONSUMER LEFT A REVIEW ON AMAZON.COM STATING THAT THE INTELISWAB SWAB WAS A HARSH MATERIAL AND CAUSED BLEEDING WHICH TRANSFERRED TO THE SWAB AND TEST SOLUTION. ORASURE TECHNOLOGIES, INC REACHED OUT TO AMAZON IN AN ATTEMPT TO CONTACT THIS CONSUMER FOR MORE INFORMATION ABOUT THIS COMPLAINT. ORASURE TECHNOLOGIES, INC. IS UNABLE TO CONTACT CONSUMER PER AMAZON DIRECTIVES. NO FURTHER ACTION IS TO BE EXPECTED WITH THIS COMPLAINT AND THE INCIDENT WILL BE CLOSED INTERNALLY.

    Description of Event or Problem · 0

    CONSUMER POSTED TO AMAZON.COM THE FOLLOWING REVIEW STATING: 'WOULD NOT RECOMMEND THIS COVID RAPID TEST. FIRST, IT IS A 30 MINUTE WAIT DID NOT SEE THIS IN THE DESCRIPTION. STANDARD ARE A 10-15 MINUTE WAIT. THE SWAB IS A HARSH MATERIAL AND CAUSED MORE BLEEDING THAN SPOTTING WHICH TRANSFERRED TO THE LIQUID. IT WAS DIFFICULT TO READ.'

    Description of Event or Problem · 0

    CONSUMER POSTED TO AMAZON.COM THE FOLLOWING REVIEW STATING: 'WOULD NOT RECOMMEND THIS COVID RAPID TEST. FIRST, IT IS A 30 MINUTE WAIT DID NOT SEE THIS IN THE DESCRIPTION. STANDARD ARE A 10-15 MINUTE WAIT. THE SWAB IS A HARSH MATERIAL AND CAUSED MORE BLEEDING THAN SPOTTING WHICH TRANSFERRED TO THE LIQUID. IT WAS DIFFICULT TO READ.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145795 INTELISWAB COVID-19 RAPID TEST INTELISWAB QKP ORASURE TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown