BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKVUE AT-HOME OTC COVID-19 TEST

    MDR report key: 12492923 · Received September 17, 2021

    Report

    Report Number
    0002024674-2021-00049
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 17, 2021
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    QKP
    UDI-DI
    30014613339724
    PMA / PMN Number
    EUA210269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP TO CORRECT THE PRODUCT CODE TO QKP.

    Description of Event or Problem · 0

    OTC QV COVID- HUSBAND SWABBED WIFE NOSE CAUSING PAIN AND BLEEDING.

    Additional Manufacturer Narrative · 1

    SUBJECT: OTC QV COVID- HUSBAND SWABBED WIFE NOSE CAUSING PAIN AND BLEEDING. INVESTIGATION CONCLUSION: A REVIEW OF THE PRODUCT DID NOT FIND ANY UNUSUAL TREND FOR THE REPORTED COMPLAINT CATEGORY. WITHOUT A LOT NUMBER, NO FURTHER INVESTIGATION CAN BE CONDUCTED. INVESTIGATION SUMMARY: IN RESPONSE TO YOUR COMPLAINT, WE PERFORMED A SEARCH FOR SIMILAR COMPLAINTS OF THE REPORTED PROBLEM. NO ADVERSE TREND WAS OBSERVED. WITHOUT PRODUCT LOT INFORMATION, NO FURTHER TESTING COULD BE CONDUCTED. ALTHOUGH WE WERE UNABLE TO DUPLICATE YOUR COMPLAINT, THE INFORMATION YOU PROVIDED HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR / INSUFFICIENT INFO.

    Description of Event or Problem · 1

    OTC QV COVID- HUSBAND SWABBED WIFE NOSE CAUSING PAIN AND BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386591 QUICKVUE AT-HOME OTC COVID-19 TEST QUICKVUE AT-HOME OTC COVID-19 TEST QKP QUIDEL CORPORATION 20402 30014613339724

    Patients

    Seq Age Sex Outcome Treatment
    1