MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL; 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)
Type of Reportable Event	Malfunction
Event or Problem Description
Foam strips were reported to detach from the bottom of the boot covers during use.No slips or falls occurred during use, and no medical or surgical intervention was required.Similar incidents have previously resulted in slips and falls; therefore, this complaint is being reported as a failure which is likely to cause a serious injury or illness should it recur.
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 hi guard ultra full coverage boot universal, part number 69672 is contract manufactured by (b)(4) (fda registration number (b)(4)).Supplier corrective action request (scar) was submitted to the manufacturer on march 27, 2026.A follow-up report will be provided upon conclusion of investigation and response by the contract 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.

• Brand Name: HALYARD HI GUARD ULTRA FULL COVERAGE BOOT UNIVERSAL
• 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: 24798431
• Report Number: 3014421917-2026-00006
• Device Sequence Number: 16129050
• Product Code: FXP
• UDI-Device Identifier: 30680651696725
• UDI-Public: 30680651696725
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/20/2026

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: HX25239100, HX25301372
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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