MAUDE Adverse Event Report: O&M HALYARD, INC. XTRA TRAC SHOEC, XLG; SHOE COVER

Model Number	69254
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event is available but has not been received.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard* x-tra traction* shoe cover, xl, blue.The complaint component halyard* x-tra traction* shoe cover, xl, blue, part number 69254 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 august 1, 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.
Event or Problem Description
The customer has reported a potential safety concern involving the use of shoe covers.Specifically, they indicated that the covers are slippery.As a result, one employee experienced a near-fall incident which caused minor back strain.No serious injury has been reported at this time.Follow-up questions were submitted to the customer to gather additional details regarding the incident.As of the date of this report, no responses have been received.
Additional Manufacturer Narrative
Two retained samples from complaint lot hx24358819 were inspected by the manufacturer, hubei xinxin non-woven co., ltd.Upon visual inspection, no abnormalities were observed in the printed pattern on the bottom surface.According to the test report, both the static and kinetic friction values are greater than 0.6, which meets the requirements of fabric specification.A review of the device history record found no abnormalities.All incoming, in-process, and final inspections were completed without deviations, and all results were within specification limits.Although a root cause could not be identified, customers have been advised to exercise caution when using shoe covers on waxed or wet floors.To address the issue, the following measures have been implemented.: in addition to the existing cof (coefficient of friction) test requirements, an additional test has been implemented in the cutting workshop to support further data analysis.A deviation was initiated to increase the amount of glue applied to the fabric, ensuring that the individual friction coefficient reaches at least 0.7, with an average cof value above 0.8.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.

• Brand Name: XTRA TRAC SHOEC, XLG
• Common Device Name: SHOE COVER
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): HUBEI XINXIN NON-WOVEN CO., LTD; taizihu industrial park; pengchang town xiantao; hubei, china
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 22749947
• Report Number: 3014421917-2025-00038
• Device Sequence Number: 8606868
• Product Code: FXP
• UDI-Device Identifier: 30680651692543
• UDI-Public: 30680651692543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 69254
• Device Catalogue Number: 991069254
• Device Lot Number: HX24358819
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown