BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IHEALTH

    MDR report key: 14911709 · Received July 4, 2022

    Report

    Report Number
    3008573045-2022-00150
    Event Type
    Injury
    Date Received
    July 4, 2022
    Date of Event
    May 9, 2022
    Report Date
    July 4, 2022
    Manufacturer
    ANDON MEDICAL CO.,LTD
    Product Code
    QKP
    UDI-DI
    20856362005894
    PMA / PMN Number
    EUA210470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IHEALTH LABS, INC., CUSTOMER SERVICE HAS REACHED OUT TO THE SITE VIA EMAIL WITH SEVERAL QUESTIONS POSED TO THE SITE/USER, AND HAS NOT RECEIVED ANY RESPONSES TO DATE. INITIAL REPORT SUGGESTS THE LEVEL AND DEGREE OF THE ALLERGIC REACTION WAS NOT PROVIDED. NO INFORMATION TO SUGGEST THE PATIENT HAD RECEIVED ANY ADDITIONAL TREATMENT OR MEDICAL INTERVENTION AS A RESULT OF THE ALLERGIC REACTION. THERE WAS NO INFORMATION DETAILING THE PATIENT'S PRE-EXISTING CONDITIONS PRIOR TO USE, AND IF ANY, PATIENT IS PRONE TO ALLERGIC REACTION, SPECIFICALLY WITH THE USE OF IHEALTH COVID-19 ANTIGEN TEST KIT(S) AND ITS COMPONENTS. USER DID NOT PROVIDE SPECIFIC PRODUCT INFORMATION OR PICTURES, WE WILL FOLLOW-UP WITH THE SITE TO GATHER ADDITIONAL INFORMATION RELATING TO THIS EVENT.

    Description of Event or Problem · 0

    CUSTOMER FEEDBACK: "ALLERGIC REACTION I EXPERIENCED AFTER USING THE SWAB."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161947 IHEALTH COVID-19 ANTIGEN RAPID TEST QKP ANDON MEDICAL CO.,LTD ICO-3000 20856362005894

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Other| R