BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRA TRAC SHOEC, XLG

    MDR report key: 22749947 · Received August 8, 2025

    Report

    Report Number
    3014421917-2025-00038
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Report Date
    September 23, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO RETAINED SAMPLES FROM COMPLAINT LOT HX24358819 WERE INSPECTED BY THE MANUFACTURER, HUBEI XINXIN NON-WOVEN CO., LTD. UPON VISUAL INSPECTION, NO ABNORMALITIES WERE OBSERVED IN THE PRINTED PATTERN ON THE BOTTOM SURFACE. ACCORDING TO THE TEST REPORT, BOTH THE STATIC AND KINETIC FRICTION VALUES ARE GREATER THAN 0.6, WHICH MEETS THE REQUIREMENTS OF FABRIC SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ABNORMALITIES. ALL INCOMING, IN-PROCESS, AND FINAL INSPECTIONS WERE COMPLETED WITHOUT DEVIATIONS, AND ALL RESULTS WERE WITHIN SPECIFICATION LIMITS. ALTHOUGH A ROOT CAUSE COULD NOT BE IDENTIFIED, CUSTOMERS HAVE BEEN ADVISED TO EXERCISE CAUTION WHEN USING SHOE COVERS ON WAXED OR WET FLOORS. TO ADDRESS THE ISSUE, THE FOLLOWING MEASURES HAVE BEEN IMPLEMENTED.: IN ADDITION TO THE EXISTING COF (COEFFICIENT OF FRICTION) TEST REQUIREMENTS, AN ADDITIONAL TEST HAS BEEN IMPLEMENTED IN THE CUTTING WORKSHOP TO SUPPORT FURTHER DATA ANALYSIS. A DEVIATION WAS INITIATED TO INCREASE THE AMOUNT OF GLUE APPLIED TO THE FABRIC, ENSURING THAT THE INDIVIDUAL FRICTION COEFFICIENT REACHES AT LEAST 0.7, WITH AN AVERAGE COF VALUE ABOVE 0.8. 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

    THE PRODUCT INVOLVED IN THE EVENT IS AVAILABLE BUT HAS NOT BEEN RECEIVED. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD* X-TRA TRACTION* SHOE COVER, XL, BLUE. THE COMPLAINT COMPONENT HALYARD* X-TRA TRACTION* SHOE COVER, XL, BLUE, PART NUMBER 69254 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 AUGUST 1, 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.

    Description of Event or Problem · 0

    THE CUSTOMER HAS REPORTED A POTENTIAL SAFETY CONCERN INVOLVING THE USE OF SHOE COVERS. SPECIFICALLY, THEY INDICATED THAT THE COVERS ARE SLIPPERY. AS A RESULT, ONE EMPLOYEE EXPERIENCED A NEAR-FALL INCIDENT WHICH CAUSED MINOR BACK STRAIN. NO SERIOUS INJURY HAS BEEN REPORTED AT THIS TIME. FOLLOW-UP QUESTIONS WERE SUBMITTED TO THE CUSTOMER TO GATHER ADDITIONAL DETAILS REGARDING THE INCIDENT. AS OF THE DATE OF THIS REPORT, NO RESPONSES HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249611 XTRA TRAC SHOEC, XLG SHOE COVER FXP O&M HALYARD, INC. 69254 HX24358819 30680651692543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown