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

Model Number	69253
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
One of the staff members slipped and fell in the autopsy room.The shoe cover does not provide sufficient skid resistance.There was no injury or medical treatment required due to fall.
Additional Manufacturer Narrative
The product involved in the event is not available for evaluation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard* x-tra traction* shoe cover, xl, blue.The complaint product halyard* x-tra traction* shoe cover, xl, blue, part number 69254 is contract manufactured by lianyungang anson non-woven product co., ltd.(fda registration number 3008959420).Supplier corrective action request (scar) was submitted to the manufacturer on september 12, 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.
Additional Manufacturer Narrative
****correction***** the product code reported in the initial report was 69254; however, the correct product code should have been 69253.The actual product sample was not provided; therefore, the investigation was conducted through a review of the device history record (dhr) and process documentation.The raw materials used in the product remain unchanged.All materials passed incoming inspections, and no abnormalities were identified during the device history record review or process investigation.This marks the first reported adhesion issue in the past 12 months for product code 69253, lot number ax20273008.The affected item was originally manufactured by lianyungang anson non-woven product co., ltd., which ceased production in 2022.Manufacturing responsibilities have since transitioned to hubei xinxin non-woven co., ltd (us registration #3011547453), following approved change requests.At this time, no further action is planned.Hubei xinxin non-woven co., ltd will continue to closely monitor field performance to identify any emerging trends.This product incident is documented in the o&m halyard, inc.Complaint database and identified as (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: 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): LIANYUNGANG ANSON NON-WOVEN PRODUCTS CO., LTD.; no.9, hongkong rd; ganyu economic development zone; lianyungang jiangsu, china
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd.; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 23076274
• Report Number: 3014421917-2025-00039
• Device Sequence Number: 17339918
• Product Code: FXP
• UDI-Device Identifier: 30680651692543
• UDI-Public: 30680651692543
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 69253
• Device Catalogue Number: 991069254
• Device Lot Number: AX20273008
• 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: 09/05/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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