BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRA TRACTION SHOECVR

    MDR report key: 19085262 · Received April 10, 2024

    Report

    Report Number
    3014421917-2024-00005
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    November 5, 2023
    Report Date
    June 6, 2024
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    FXP
    UDI-DI
    30680651692529
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT ONE. THE PRODUCT INVOLVED IN THE EVENT IS AVAILABLE FOR EVALUATION BUT 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: 69252 IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER: 3011547453. A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE CONTRACT MANUFACTURER ON 15MAR2024. 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.

    Additional Manufacturer Narrative · 0

    INCIDENT ONE O&M HALYARD, INC. IS THE SPECIFICATION DEVELOPER AND COMPLAINT HANDLING ESTABLISHMENT OF THE X-TRA TRACTION* SHOE COVER, UNIVERSAL SIZE, BLUE. THE COMPLAINT PRODUCT IS CONTRACT MANUFACTURED BY HUBEI XINXIN NON-WOVEN CO., LTD (FDA REGISTRATION NUMBER (B)(4). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE CONTRACT MANUFACTURER ON MARCH 14, 2024. SAMPLES WERE RECEIVED FROM THE CUSTOMER. VISUAL INSPECTION CONFIRMED NO ISSUES. TEN SAMPLES WERE SENT TO LAB FOR FRICTION TESTING. ALL RESULTS WERE FOUND TO MEET SPECIFICATION. DEVICE HISTORY RECORDS WERE REVIEWED, ALL INCOMING, IN-PROCESS AND FINAL INSPECTIONS WERE WITHIN SPECIFICATION. NO ROOT CAUSE WAS IDENTIFIED. O&M HALYARD AND CONTRACT MANUFACTURER WILL CONTINUE TO PERFORM TRACKING AND TRENDING. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (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 ONE. PER CUSTOMER THEY HAVE SOME CONCERNS WITH THE TRACTION OF THE SHOE COVERS THEY'VE RECEIVED. THEY'VE HAD STAFF MEMBERS SLIP AND FALL WHILE WEARING THEM. THE FIRST INCIDENT OCCURRED ON (B)(6) 2023. FOR THIS FIRST INCIDENT ON (B)(6), THE EMPLOYEE HAD TO GET STITCHES. THERE WAS NO HOSPITAL STAY FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406886 XTRA TRACTION SHOECVR PROTECTIVE APPAREL FXP O&M HALYARD, INC. 69252 HX22075799 30680651692529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other