BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANOS CLOTEST

    MDR report key: 17624345 · Received August 24, 2023

    Report

    Report Number
    MW5144957
    Event Type
    Other
    Date Received
    August 24, 2023
    Report Date
    August 21, 2023
    Manufacturer
    AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
    Product Code
    LYR
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AVANOS CLOTEST BEING SOLD TO HOSPITALS AS AN FDA APPROVED WAIVED TEST. IT IS NOT LOCATED ON THE FDA ACCESSDATA WEBSITE. HOSPITALS ARE UTILIZING THIS TEST KIT THINKING THEY ARE USING AN FDA APPROVED KIT WHEN IN ACTUALITY THEY ARE NOT AND COULD BE CITED BY CLIA (CMS) FOR UTILIZING AN UNAPPROVED TEST. NOT FDA APPROVED; NOT CLASSIFIED ON THE FDA WEBSITE FOR COMPLEXITY. BEING SOLD TO HOSPITALS SAYING THEY ARE FDA APPROVED AND HAVE BEEN DETERMINED TO BE WAIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726676 AVANOS CLOTEST HELICOBACTER PYLORI LYR AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown