MAUDE Adverse Event Report: O&M HALYARD, INC. XTRA TRACTION SHOECVR; PROTECTIVE APPAREL

Model Number	69252
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident two the product involved in the event is available for evaluation but has not been returned at the time of this report.O&m halyard, inc.Is the specification developer and complaint handling establishment of the x-tra traction* shoe cover, universal size, blue.The complaint component x-tra traction* shoe cover, universal size, blue, part number 69252 is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number 3011547453).A supplier corrective action (scar) was submitted to the contract manufacturer on 15mar2024.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.
Event or Problem Description
Incident two per customer they have some concerns with the traction of the shoe covers they've received.They've had staff members slip and fall while wearing them.The second incident occurred on february 15, 2024.For this incident in february, the employee was put on modified duty due to injury to the lower back and wrist from the fall.There was no hospital stay for this patient.
Additional Manufacturer Narrative
Incident two o&m halyard, inc.Is the specification developer and complaint handling establishment of the x-tra traction* shoe cover, universal size, blue.The complaint product is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number (b)(4).A supplier corrective action (scar) was submitted to the contract manufacturer on march 14, 2024.Samples were received from the customer.Visual inspection confirmed no issues.Ten samples were sent to lab for friction testing.All results were found to meet specification.Device history records were reviewed, all incoming, in-process and final inspections were within specification.No root cause was identified.O&m halyard and contract manufacturer will continue to perform tracking and trending.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 TRACTION SHOECVR
• Common Device Name: PROTECTIVE APPAREL
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; 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 early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19085263
• Report Number: 3014421917-2024-00006
• Device Sequence Number: 12675392
• Product Code: FXP
• UDI-Device Identifier: 30680651692529
• UDI-Public: 30680651692529
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2024

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: 69252
• Device Catalogue Number: 991069252
• Device Lot Number: HX22075799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown