BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-TRA TRACTION SHOE COVER BLUE UNIV

    MDR report key: 22309632 · Received June 23, 2025

    Report

    Report Number
    3014421917-2025-00015
    Event Type
    Injury
    Date Received
    June 23, 2025
    Report Date
    July 14, 2025
    Manufacturer
    O&M HALYARD, INC
    Product Code
    FXP
    UDI-DI
    30680651692529
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT FOUR OF SEVEN. 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 X-TRA TRACTION SHOE COVER BLUE UNIV. THE COMPLAINT COMPONENT X-TRA TRACTION SHOE COVER BLUE UNIV, PART NUMBER 69252 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 JUNE 5, 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

    INCIDENT FOUR. THE DEVICE HISTORY RECORDS FOR THE COMPLAINT LOT WERE REVIEWED, AND THE STATIC AND KINETIC FRICTION VALUES EXCEEDED 0.6, MEETING THE SPECIFIED ACCEPTANCE CRITERIA. WEAR TESTING, CONDUCTED FOR 15 MINUTES PER PRODUCTION LOT, CONFIRMED CONFORMANCE. INSPECTION RESULTS FROM INCOMING, IN-PROCESS, AND FINAL PRODUCT EVALUATIONS WERE ALL WITHIN SPECIFICATION. RETAINED SAMPLES FROM THE COMPLAINT LOT WERE ALSO EXAMINED AND FOUND TO BE CONFORMING, WITH NO OBSERVABLE ISSUES. ADDITIONALLY, A 4-HOUR WEAR TEST WAS CONDUCTED ON THE RETAINED SAMPLES, DURING WHICH NO SLIPPAGE OR ADHESIVE FAILURES WERE OBSERVED. AT THE END OF 2022, THE HOT MELT ADHESIVE SOURCE WAS CHANGED FROM U.S. FACILITY TO CHINA FACILITY, WHICH INVOLVED A MINOR FORMULATION ADJUSTMENT. NO SIMILAR COMPLAINTS WERE REPORTED PRIOR TO THIS CHANGE; HOWEVER, SINCE THE TRANSITION, SIMILAR ISSUES HAVE BEEN OBSERVED. AS A PRECAUTION, A FORMAL CHANGE CONTROL HAS BEEN INITIATED TO REVERT TO THE ORIGINAL HOT MELT ADHESIVE PREVIOUSLY SOURCED FROM THE U.S. FACILITY. ADDITIONALLY, AN INCREASED AMOUNT OF ADHESIVE HAS BEEN APPROVED FOR USE DURING MANUFACTURING, RAISING THE COEFFICIENT OF FRICTION TO 0.7. ENHANCED TESTING MEASURES HAVE ALSO BEEN IMPLEMENTED IN THE CUTTING WORKSHOP TO PROACTIVELY DETECT ANY SIMILAR ISSUES. 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

    INCIDENT FOUR. OWENS & MINOR SALES REPRESENTATIVE WAS VISITING THE FACILITY WHEN SHE WAS INFORMED THERE WERE TWO INCIDENTS INVOLVING HALYARD SHOE COVERS. ONE EMPLOYEE HAD FALLEN AND ANOTHER SLIPPED WHILE WEARING. NEITHER EMPLOYEE REQUIRED MEDICAL ASSISTANCE. ADDITIONAL INCIDENT FOLLOW UP QUESTIONS WERE ASKED TO USER, AND ANSWERS RECEIVED ON JUNE 11, 2025. THIS COMMUNICATION INDICATED SEVEN HEALTHCARE PERSONNEL SUFFERED FALLS WHILE USING THE SHOE COVERS AND TWO EMPLOYEES DID NOT RETURN TO WORK, THEY SUFFERED BLOWS TO THE HEAD/BACK CAUSED BY FALLS THAT REQUIRED THEM TO GO ON DISABILITY. THE PERSONNEL WERE GIVEN TREATMENT FOR PAIN TO REDUCE INFLAMMATION IN THE AFFECTED AREAS. OWENS & MINOR ASKED WHAT MEDICATIONS, TYPE OF TREATMENT, TESTING AND MEDICATION DOSAGE WAS PROVIDED FOR INCIDENT, THE REPORTER DECLINED TO PROVIDE. ALL SEVEN PERSONNEL MEMBERS VISITED EMPLOYEE HEALTH. FIFTEEN ADDITIONAL STAFF MEMBERS WERE REPORTED TO HAVE SLIP INCIDENTS WITH NO FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219042 X-TRA TRACTION SHOE COVER BLUE UNIV PROTECTIVE APPAREL FXP O&M HALYARD, INC 69252 HX24331641 30680651692529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other