MAUDE Adverse Event Report: O&M HALYARD, INC. XTRA TRAC SHOEC, XLG

Model Number	69254
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident one of two.The product involved in the event is available for return but has not been received yet.O&m halyard, inc.Is the specification developer and complaint handling establishment of the halyard, x-tra traction, shoe cover, xl, blue.The complaint component halyard, x-tra traction, shoe cover, xl, blue, part number: 69254 is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number: (b)(4).Supplier corrective action request (scar) was submitted to the manufacturer on october 8, 2024.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
Incident one.There were 2 workplace injuries reported.The customer reported the traction was insufficient.These were not serious injuries; no medical intervention was required.There was no lost time from work, only bruising.
Additional Manufacturer Narrative
Incident two.On oct 16, 2024, we received the returned sample of 69254.There was 1 shoe cover in the bag.We performed the visual inspection of the bottom pattern and found no incomplete printed pattern or visible inconsistency of glue.We sent sample to lab for static and kinetic friction test.According to hubei xinxin non-woven co., ltd internal fabric specification, the standard of static and kinetic friction should be greater than 0.6.This sample was found to meet specification.Based on returned sample investigation and retained sample investigation, all static and kinetic friction test results were found to meet specification.A wear test was conducted, wearing shoe cover in normal office environment, production environment, and laboratory environment.Each test lasts about half an hour, none of the wearers found shoe cover to be slippery and the glue coating did not come off.Device history record review, including all inspection records was conducted.All results were found to be within range with no abnormalities discovered.Based on above investigation, a root cause was not determined; however, we will continue tracking and trending of complaints to determine if corrective actions are warranted.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: XTRA TRAC SHOEC, XLG
• Common Device Name: XTRA TRAC SHOEC, XLG
• 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: 20474939
• Report Number: 3014421917-2024-00009
• Device Sequence Number: 7228064
• Product Code: FXP
• UDI-Device Identifier: 30680651692543
• UDI-Public: 30680651692543
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: 991069254
• Device Lot Number: HX24118370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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