BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD X-TRA TRACTION SHOE COVER, XL, BLUE

    MDR report key: 21397688 · Received February 18, 2025

    Report

    Report Number
    3014421917-2025-00006
    Event Type
    Injury
    Date Received
    February 18, 2025
    Report Date
    March 27, 2025
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    UDI-DI
    30680651692543
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLES WERE AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW REVEALED NO ABNORMALITIES, INCOMING, IN-PROCESS AND FINAL INSPECTIONS WERE COMPLETED WITHOUT DEVIATIONS. ALL RESULTS WERE WITHIN SPECIFICATION LIMITS. THE CUSTOMER HAS CONFIRMED THAT PREVIOUSLY THE CLEANING TEAM WAS WET AND DRY MOPPING THE AREA, THERE WAS LESS FEEDBACK INDICATING SLIPPAGE DURING THAT TIME. THE CUSTOMER MADE A STATEMENT IN RESPONSE EMAIL INDICATING THIS INCIDENT WAS DUE TO PLACING TOO MUCH WEIGHT ON THE HEEL OF THE SHOE COVER. THERE HAVE BEEN NO CHANGES TO THE GLUE SUPPLIER. A WEAR TEST FOR 15 MINUTES IS CONDUCTED FOR EACH LOT MANUFACTURED. SOME RETAINED SAMPLES FROM LOT NUMBER HX24165657 WERE EVALUATED. THE SAMPLES WERE SENT TO LAB FOR STATIC AND KINETIC FRICTION TEST. THE TEST RESULTS WERE GREATER THAN 0.6, MEETING THE SPECIFICATION ACCEPTANCE CRITERIA. THE MANUFACTURER HAS IMPLEMENTED ADDITIONAL TESTING IN THE CUTTING WORKSHOP. THE MANUFACTURER HAS INCREASED THE AMOUNT OF GLUE APPLIED ON THE FABRIC TO ENSURE THAT THE INDIVIDUAL FRICTION COEFFICIENT VALUE CAN REACH 0.7. THERE IS A CAUTION WARNING ON THE PRODUCT THAT STATES, "THE RISK OF SLIPPING EXISTS, ESPECIALLY ON WAXED FLOOR OR WET FLOORS." 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE HALYARD X-TRA TRACTION SHOE COVER, XL, BLUE. THE COMPLAINT SHOE COVER IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER: (B)(4). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON FEBRUARY 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 A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    A SAFETY EVENT SLIP/FALL OCCURRED WHILE WEARING THE SHOE COVERS. THE CUSTOMER ALLEGED THIS INCIDENT WAS DUE TO PLACING TOO MUCH WEIGHT ON THE HEEL OF THE SHOE COVER. A QUESTIONNAIRE WAS SENT TO CUSTOMER ON FEBRUARY 6, 10, AND 13TH TO ACQUIRE MORE DETAILS ABOUT REPORTED INCIDENT. NO RESPONSE HAS BEEN RECEIVED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478091 HALYARD X-TRA TRACTION SHOE COVER, XL, BLUE PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69254 HX24165657 30680651692543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other