MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD HI GUARD ULTRA FULL COVERAGE BOOT, XL; PROTECTIVE APPAREL

Model Number	69672
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	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event is not available for return.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard hi guard ultra full coverage boot xl.The complaint component halyard hi guard ultra full coverage boot xl, part number 69672 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 june 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Surgeon states there is minimal grip on the bottom of shoe cover.The surgeon needs grip to ream in some of their cases and he is unable to do so safely without sliding on floor.He has slipped/slid while wearing them.The tread falls off and sticks to floor instead of the boot.Surgeon states he's almost fallen even on dry floor.
Additional Manufacturer Narrative
No sample was returned for evaluation.The supplier conducted a review and testing of retained samples from lot hx25053030.Visual inspection revealed no issues with the black foam strip detaching.On july 10, 2025, wear tests were performed using the retained samples in three different environments: a normal office, a laboratory floor, and a workshop floor.Each test lasted approximately 30 minutes.No slipping occurred, and the black foam strip at the bottom remained intact throughout tests.Device history record (dhr) was reviewed.All in-process and final inspections were completed with no deviations noted, and no issues were identified in the final inspection records.No root cause was identified.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 HI GUARD ULTRA FULL COVERAGE BOOT, XL
• 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
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 22308931
• Report Number: 3014421917-2025-00034
• Device Sequence Number: 15437528
• Product Code: LYU
• UDI-Device Identifier: 90680651696727
• UDI-Public: 90680651696727
• 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): 08/13/2025

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: 69672
• Device Catalogue Number: 991069672
• Device Lot Number: HX25053030
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/13/2025
• 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