BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL

    MDR report key: 24960936 · Received April 22, 2026

    Report

    Report Number
    3014421917-2026-00007
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Report Date
    May 27, 2026
    Manufacturer
    O&M HALYARD, INC
    Product Code
    FXP
    UDI-DI
    20680651695721
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT IS NOT AVAILABLE FOR EVALUATION. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL. THE COMPLAINT COMPONENT HALYARD HI GUARD ULTRA FULL COVERAGE BOOT, UNIVERSAL, PART NUMBER 69572 IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER 3011547453). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON APRIL 16, 2026. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE MANUFACTURER. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE TRACTION BLACK STRIP ON THE BOTTOM OF THE BOOT COVER WAS REPORTED TO PEEL OFF WHILE STAFF WERE IN THE PATIENT¿S ROOM PERFORMING ROUTINE NURSING CARE. AS A RESULT, THE BOOT COVERS WERE PERCEIVED AS SLIPPERY, SLOWING STAFF MOVEMENT, PARTICULARLY IN HIGH-LEVEL INFECTIOUS DISEASE SETTINGS DUE TO CONCERNS ABOUT POTENTIAL SLIPS OR FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333412 HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL PROTECTIVE APPAREL FXP O&M HALYARD, INC 69572 HX23214767 20680651695721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown