BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD X-TRA TRACTION SHOE COVER XL BLUE

    MDR report key: 20921279 · Received December 12, 2024

    Report

    Report Number
    3014421917-2024-00020
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    October 28, 2024
    Report Date
    January 8, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: COMPLAINANT PROVIDED FURTHER CLARIFICATION THAT THERE WERE 4 POTENTIAL LOT NUMBERS FOR INCIDENT INCLUDING LOT NUMBERS: HX24196801, HX23302143, HX24086223 AND HX24120370. SUSPECT MEDICAL DEVICE LOT NUMBER HAS BEEN UPDATED TO UNKNOWN PROVIDED THE COMPLAINANT WASN'T ABLE TO CONFIRM WHICH LOT CONTRIBUTED TO INCIDENT. ON DECEMBER 9, 2024, RETURNED SAMPLES WERE RECEIVED FOR PRODUCT 69254. THERE WERE 4 DISPENSERS OF SHOE COVERS. MANUFACTURER PERFORMED THE VISUAL INSPECTION OF THESE FOUR BOXES, ALL COMPLAINT SAMPLES PASSED VISUAL INSPECTION. SAMPLES WERE SENT TO THE LAB FOR STATIC AND KINETIC FRICTION TEST. ACCORDING TO FABRIC SPECIFICATION, THE RECEIVING STANDARD OF STATIC AND KINETIC FRICTION SHOULD BE GREATER THAN 0.6. SAMPLES TESTED WERE ALL FOUND TO MEET AND/OR EXCEED MINIMUM SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW OF ALL REPORTED POTENTIAL COMPLAINT LOTS WAS PERFORMED, ALL IN-COMING AND FINAL INSPECTIONS WERE COMPLETED WITHOUT ANY DEVIATIONS AND FOUND TO BE WITHIN SPECIFICATION. TEMPERATURE AND HUMIDITY RECORDS WERE REVIEWED DURING LOT STORAGE TIME PERIODS, NO CONDITIONS WERE REPORTED THAT WOULD CONTRIBUTE TO FABRIC PERFORMANCE. ACCORDING TO THE FAILURE, THERE MAY BE THE FOLLOWING REASONS FOR THE NON-SKID OF THE FABRIC: 1. RAW MATERIAL (GLUE) LEADS TO THE NON-SKID OF THE PRODUCT. MANUFACTURER EVALUATED THE SUPPLIER OF THE GLUE AND THE TEST REPORT OF THE FABRIC AND FOUND NO CONTRIBUTING ISSUES. 2. HOLES AND LEAKS CAUSED BY UNEVEN GLUE APPLICATION. MANUFACTURER DID NOT FIND ANY HOLES OR UNEVENNESS IN GLUE APPLICATION ON THE RECEIVED COMPLAINT SAMPLES. THE MANUFACTURER HAS INDICATED THEY WILL CONDUCT VISUAL INSPECTION OF EACH FABRIC ROLL PRODUCED TO ENSURE THERE ARE NO PROBLEMS. 3. IMPROPER USE ENVIRONMENT. MANUFACTURER HAS CONDUCTED WEAR TESTING ON PRODUCT. MANUFACTURER HAS CONFIRMED THERE HAVE BEEN NO CHANGES IN THE GLUE SUPPLIER. PER THE INSTRUCTIONS DISPLAYED ON THE DISPENSER ATTACHED, IT CLEARLY STATES CAUTION " THE RISK OF SLIPPING EXISTS, ESPECIALLY ON WAXED 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 AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT HAS NOT BEEN RETURNED AT THE TIME OF THIS REPORT. O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE X-TRA TRACTION* SHOE COVER, UNIVERSAL SIZE, BLUE. THE COMPLAINT COMPONENT X-TRA TRACTION* SHOE COVER, UNIVERSAL SIZE, BLUE, PART NUMBER 69254 IS CONTRACT MANUFACTURED BY (B)(4) (FDA REGISTRATION NUMBER 3011547453). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE CONTRACT MANUFACTURER ON NOVEMBER 21, 2024. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE CONTRACT 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

    COMPLAINT WAS RECEIVED ON NOVEMBER 18, 2024, INDICATING SHOE COVERS ARE SLIPPERY. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 22, 2024. A SURGICAL TECHNICIAN WAS WALKING IN THE OR, TO CLEAN UP AFTER THE CASE WAS COMPLETE, WHEN THEY SLIPPED, FELL, AND HIT THEIR HEAD. THE DATE OF THE EVENT WAS OCTOBER 28, 2024. THE EMPLOYEE SUFFERED A CONCUSSION AND REQUIRED TREATMENT. THE EMPLOYEE IS STABLE, AND APPROPRIATE REPORTING HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804837 HALYARD X-TRA TRACTION SHOE COVER XL BLUE PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69254 UNKNOWN 30680651692543

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other