MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD X-TRA TRACTION SHOE COVER, XL, BLUE; PROTECTIVE APPAREL

Model Number	69254
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: HALYARD X-TRA TRACTION SHOE COVER, XL, BLUE
• Common Device Name: PROTECTIVE APPAREL
• 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 43301 8; CH 433018
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd.; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21397688
• Report Number: 3014421917-2025-00006
• Device Sequence Number: 9199595
• Product Code: FXP
• UDI-Device Identifier: 30680651692543
• UDI-Public: 30680651692543
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 69254
• Device Catalogue Number: 69254
• Device Lot Number: HX24165657
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown