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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The operating room reported "slippage" while wearing the shoe covers.There was no injury reported at time of complaint receipt.Additional follow up questionnaire was sent to customer on february 3, 6, and 10th to acquire additional details.No response has been received at this time.
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 shoe cover is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number 3011547453).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.
Additional Manufacturer Narrative
No samples were available for evaluation.The device history record evaluation was performed on the lot number reported and the product was manufactured according to specifications.There have been no changes to the glue supplier.A wear test for 15 minutes is conducted for each lot manufactured.Retained samples at the manufacturing site were tested and found with no abnormalities.The manufacturer has implemented additional testing in the cutting work shop.The manufacturer has increased the amount of glue applied on the fabric to ensure that the individual friction coefficient value can reach 0.7.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: 21398615
• Report Number: 3014421917-2025-00007
• Device Sequence Number: 7586210
• Product Code: FXP
• UDI-Device Identifier: 30680651692543
• UDI-Public: 30680651692543
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 03/24/2025

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: 69254
• Device Lot Number: HX24162657
• 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: 03/24/2025
• 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