MAUDE Adverse Event Report: O&M Halyard, Inc. HALYARD ANKLE GUARD Shoe Cover XL; Protective Apparel

Model Number	69353
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	Serious Injury

• Brand Name: HALYARD ANKLE GUARD Shoe Cover 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 43301 8
• Manufacturer Contact: angela weaver ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; +1(770)401-1697
• MDR Report Key: 50230401
• Report Number: 3014421917-2026-00024
• Device Sequence Number: 10273697
• Product Code: FXP
• UDI-Device Identifier: 20680651693536
• UDI-Public: 20680651693536
• 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): 09/04/2026

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: 69353
• Device Catalogue Number: 69353
• Device Lot Number: HX25002844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/08/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown