BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRA TRAC SHOEC, XLG

    MDR report key: 20580083 · Received October 31, 2024

    Report

    Report Number
    3014421917-2024-00015
    Event Type
    Injury
    Date Received
    October 31, 2024
    Report Date
    December 18, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DEVICE HISTORY RECORD REVIEW, NO ABNORMALITIES OCCURRED DURING MANUFACTURE. A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. INSPECTION RESULTS FROM COMPLAINT LOT WERE REVIEWED, ALL STATIC AND KINETIC FRICTION RESULTS WERE GREATER THAN 0.6, WHICH MEETS THE REQUIREMENT FOR FABRIC SPECIFICATION. INCOMING, IN-PROCESS AND FINAL INSPECTIONS WERE COMPLETED WITHOUT ANY DEVIATIONS, ALL INSPECTIONS WERE WITHIN SPECIFICATIONS LIMITS. IN DECEMBER 2022, THE ANTI-SLIP ADHESIVE GLUE AT THE BOTTOM OF THE BOOT COVER WAS CHANGED FROM IMPORTED TO DOMESTIC, BUT THE SUPPLIER DID NOT CHANGE. DUE TO THE BETTER FLUIDITY OF DOMESTIC GLUE, THE CONTRACT MANUFACTURER REDUCED THE AMOUNT OF GLUE APPLIED, BUT THE ACTUAL STATIC AND KINETIC FRICTION VALUE OF THE FABRIC DID NOT DECREASE, WHICH WAS VERIFIED AT THAT TIME. RETAINED SAMPLES WERE TESTED. THE RESULTS WERE GREATER THAN 0.6, WHICH MEETS THE REQUIREMENT OF INTERNAL FABRIC SPECIFICATION. THE CONTRACT MANUFACTURER ARRANGED DIFFERENT EMPLOYEES TO CONDUCT A WEAR TEST IN DIFFERENT ENVIRONMENTS, INCLUDING NORMAL OFFICE ENVIRONMENT, PRODUCTION ENVIRONMENT AND LABORATORY ENVIRONMENT. EACH TEST LASTS ABOUT HALF AN HOUR, NO EMPLOYEES FOUND IT SLIPPERY, AND THE GLUE COATING DID NOT COME OFF. NO ROOT CAUSE WAS IDENTIFIED. 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 THIS EVENT IS NOT AVAILABLE FOR EVALUATION. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE COMPLAINT PRODUCT. THE PRODUCT IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER 3011547453). A SCAR WAS ISSUED TO THE CONTRACT MANUFACTURER ON OCTOBER 21, 2024. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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

    CUSTOMER REPORTED THAT SHOE COVER SEEMS INADEQUATE. THERE ARE SOME REPORTED SLIPS AND FALLS WITH REQUIRED DOWN TIME FOR STAFF TO GO TO (B)(6) TO BE EXAMINED. ALSO, OTHER STAFF MEMBERS HAVE BEEN SLIDING BUT CATCHING THEMSELVES WITH NO ASSOCIATED INJURY(IES). THERE HAVE BEEN A FEW SLIPS BAD ENOUGH THAT REQUIRED PROMPT CARE VISITS. ADDITIONAL INFORMATION WAS REQUESTED ON OCTOBER18, 2024, AND OCTOBER 21, 2024; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1962736 XTRA TRAC SHOEC, XLG PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69254 HX24087223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other