BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVS HEALTH AT HOME, COVID-19 TEST KIT

    MDR report key: 20081505 · Received August 27, 2024

    Report

    Report Number
    0002024674-2024-00307
    Event Type
    Injury
    Date Received
    August 27, 2024
    Report Date
    August 27, 2024
    Manufacturer
    QUIDELORTHO CORPORATION
    Product Code
    QKP
    PMA / PMN Number
    EUA210269/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: A SEARCH WAS PERFORMED FOR SIMILAR COMPLAINTS OF THE REPORTED PROBLEM FOR THIS PRODUCT. NO ADVERSE TREND WAS OBSERVED FOR THE REPORTED ISSUE. SOURCE: ONLINE CUSTOMER REVIEWS.

    Description of Event or Problem · 0

    HARD PLASTIC PIECE ON SWAB CAUSING "HORRIBLE" NOSE CUTS AND "MASSIVE" NOSE BLEED WHEN SWABBING. CUSTOMER LEFT A REVIEW ON AN ONLINE RETAIL SITE: "CHECK BEFORE YOU SWAB!! I BOUGHT THIS EXACT ONE. THE NASAL SWAB ON ONE HAD A HARD PLASTIC PIECE ON IT THAT SCRAPED THE ENTIRE INSIDE OF MY NOSE CAUSING HORRIBLE CUTS AND A MASSIVE NOSE BLEED! I WASHED OFF THE BLOODY TIP BEFORE POSTING THE PICTURE. CHECK URS BEFORE STICKING IT IN UR NOSE!" TECHNICAL SUPPORT ASSESSMENT/TROUBLESHOOTING: NO TROUBLESHOOTING OR ASSISTANCE WAS PROVIDED TO THE CONSUMER. THE PRODUCT REVIEW WAS OBTAINED FROM A REVIEW OF ONLINE RETAIL SITES. CVS CUSTOMER SERVICE POSTED BELOW RESPONSE TO REVIEW "HI (B)(6), WE ARE SORRY TO HEAR ABOUT YOUR EXPERIENCE WITH THE CVS HEALTH AT HOME COVID-19 TEST KIT. WE TAKE CUSTOMER FEEDBACK VERY SERIOUSLY AND ARE COMMITTED TO PROVIDING OUR CUSTOMERS WITH HIGH QUALITY PRODUCTS. WE ENCOURAGE YOU TO CONTACT US AT 1-888-607-4CVS (1-888-607-4287). YOU CAN ALSO VISIT OUR ONLINE HELP PAGE: HTTPS://WWW.CVS.COM/HELP/HELP_INDEX.JSP. REGARDS, CVS CUSTOMER RELATIONS TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127139 CVS HEALTH AT HOME, COVID-19 TEST KIT CVS HEALTH AT HOME, COVID-19 TEST KIT QKP QUIDELORTHO CORPORATION NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown