BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL

    MDR report key: 23560309 · Received November 14, 2025

    Report

    Report Number
    3014421917-2025-00041
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Report Date
    December 30, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT IS NOT AVAILABLE FOR RETURN. 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 NOVEMBER 11, 2025. 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.

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION, THE MANUFACTURE HUBEI WAS UNABLE TO RETRIEVE THE DEVICE HISTORY RECORD (DHR) BECAUSE A LOT NUMBER WAS NOT PROVIDED. A REVIEW OF ALL OUTGOING INSPECTION RECORDS FROM THE PAST 12 MONTHS IDENTIFIED NO FINDINGS SIMILAR TO THE REPORTED COMPLAINT. THE ANTI-SLIP FOAM STRIP LOCATED ON THE BOTTOM OF THE SHOE COVER IS A PURCHASED COMPONENT. FOR EACH BATCH, THE SUPPLIER ISSUES A CERTIFICATE OF ANALYSIS TO CONFIRM COMPLIANCE WITH MATERIAL SPECIFICATIONS. INCOMING MATERIAL INSPECTIONS VERIFY LENGTH, WIDTH, AND THICKNESS REQUIREMENTS. THE MATERIAL RECORDS FOR SEVERAL RECENT BATCHES WERE REVIEWED AND FOUND ACCEPTABLE. THE SEWING PROCESS DOES NOT DAMAGE EITHER THE BASE FABRIC OR THE ANTI-SLIP FOAM STRIPS. HUBEI ALSO PERFORMED A WEAR TEST USING RETAINED SAMPLES FROM 10:00 AM TO 5:00 PM ACROSS THREE ENVIRONMENTS: A STANDARD OFFICE, A WORKSHOP FLOOR, AND A LABORATORY FLOOR. NO SLIPPING WAS OBSERVED DURING TESTING, AND THE BLACK FOAM STRIP REMAINED INTACT. IN 2024, THREE COMPLAINTS WERE RECEIVED (B)(4), AND IN 2025 TWO COMPLAINTS WERE RECEIVED (B)(4), ALL RELATED TO FOAM STRIP DETACHMENT. BECAUSE NEITHER A LOT NUMBER NOR A SAMPLE WAS PROVIDED, THE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, THE SUPPLIER WILL CONTINUE TO MONITOR, TRACK, AND TREND RELATED EVENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HI GUARD ULTRA FULL COVERAGE BOOT EXHIBITS INSUFFICIENT SLIP RESISTANCE, STATING THESE WERE TOO SLIPPERY. NO PATIENT OR END-USER HARM HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2805366 HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69672 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown