BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD HI GUARD ULTRA FULL COVERAGE BOOT XL

    MDR report key: 25080102 · Received May 5, 2026

    Report

    Report Number
    3014421917-2026-00009
    Event Type
    Injury
    Date Received
    May 5, 2026
    Report Date
    May 5, 2026
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    UDI-DI
    30680651696725
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT 2 OF 2. 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 XL, PART NUMBER 69672 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 27, 2026. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE CONTRACT 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

    TRACTION STRIPS COMING OFF THE HALYARD BOOT COVERS. ISOLATED TO STERILE PROCESSING DEPARTMENT. NO PATIENTS WERE INVOLVED, ALTHOUGH TWO STAFF MEMBERS HAVE FALLEN. ONE WENT TO THE EMERGENCY ROOM. NO MEDICAL TREATMENT OR ADMISSION WAS REQUIRED. THEY HIT THEIR HEAD AND FELL ON ELBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629596 HALYARD HI GUARD ULTRA FULL COVERAGE BOOT XL PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69672 UNKNOWN 30680651696725

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other