BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD X-TRA TRACTION SHOE COVER, XL, BLUE

    MDR report key: 23076274 · Received September 17, 2025

    Report

    Report Number
    3014421917-2025-00039
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 5, 2025
    Report Date
    November 3, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    UDI-DI
    30680651692543
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 EVALUATION. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD* X-TRA TRACTION* SHOE COVER, XL, BLUE. THE COMPLAINT PRODUCT HALYARD* X-TRA TRACTION* SHOE COVER, XL, BLUE, PART NUMBER 69254 IS CONTRACT MANUFACTURED BY LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD. (FDA REGISTRATION NUMBER 3008959420). SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON SEPTEMBER 12, 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 IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ****CORRECTION***** THE PRODUCT CODE REPORTED IN THE INITIAL REPORT WAS 69254; HOWEVER, THE CORRECT PRODUCT CODE SHOULD HAVE BEEN 69253. THE ACTUAL PRODUCT SAMPLE WAS NOT PROVIDED; THEREFORE, THE INVESTIGATION WAS CONDUCTED THROUGH A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AND PROCESS DOCUMENTATION. THE RAW MATERIALS USED IN THE PRODUCT REMAIN UNCHANGED. ALL MATERIALS PASSED INCOMING INSPECTIONS, AND NO ABNORMALITIES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW OR PROCESS INVESTIGATION. THIS MARKS THE FIRST REPORTED ADHESION ISSUE IN THE PAST 12 MONTHS FOR PRODUCT CODE 69253, LOT NUMBER AX20273008. THE AFFECTED ITEM WAS ORIGINALLY MANUFACTURED BY LIANYUNGANG ANSON NON-WOVEN PRODUCT CO., LTD., WHICH CEASED PRODUCTION IN 2022. MANUFACTURING RESPONSIBILITIES HAVE SINCE TRANSITIONED TO HUBEI XINXIN NON-WOVEN CO., LTD (US REGISTRATION #3011547453), FOLLOWING APPROVED CHANGE REQUESTS. AT THIS TIME, NO FURTHER ACTION IS PLANNED. HUBEI XINXIN NON-WOVEN CO., LTD WILL CONTINUE TO CLOSELY MONITOR FIELD PERFORMANCE TO IDENTIFY ANY EMERGING TRENDS. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS (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

    ONE OF THE STAFF MEMBERS SLIPPED AND FELL IN THE AUTOPSY ROOM. THE SHOE COVER DOES NOT PROVIDE SUFFICIENT SKID RESISTANCE. THERE WAS NO INJURY OR MEDICAL TREATMENT REQUIRED DUE TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1731386 HALYARD X-TRA TRACTION SHOE COVER, XL, BLUE PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69253 AX20273008 30680651692543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown