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

Model Number	69254
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was not available for return.O&m halyard, inc.Is the specification developer and complaint handling establishment of the x-tra traction* shoe cover, xl, blue.The complaint component x-tra traction* shoe cover, xl, blue, part number 69254 is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number 3011547453).A supplier corrective action (scar) was submitted to the manufacturer on 21mar2024.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 a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The provider was wearing shoe cover outside of the operating room and slipped.The provider did not report falling and there was no injury to the provider as a result of slipping wearing the shoe cover.The provider noted poor traction and design of the product.
Additional Manufacturer Narrative
No lot or sample was available for investigation.O&m halyard, inc.Is the specification developer and complaint handling establishment of the complaint product.The product is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number (b)(4).A scar was issued to the contract manufacturer on march 21, 2024.The contract manufacturer reviewed all outgoing inspection records april 2023 - march 2024.No problems were noted.The contract manufacturer randomly selected one product batch from warehouse to test.They performed a physical astm test, and a wear performance test over 4-hour time period.All test results were conforming.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp (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 a o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.

• Brand Name: XTRA TRAC SHOEC, XLG
• 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: 19079230
• Report Number: 3014421917-2024-00003
• Device Sequence Number: 12266231
• Product Code: FXP
• UDI-Device Identifier: 30680651692543
• UDI-Public: 30680651692543
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/03/2024

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: UNKNOWN
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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