MAUDE Adverse Event Report: O&M HALYARD, INC. HG FULL BOOT COVER; PROTECTIVE APPAREL

Model Number	69672
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 this 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 complaint product.The product is contract manufactured by hubei xinxin non-woven co., ltd (fda registration number 3011547453).A scar was issued to the contract manufacturer on may 9, 2024.A follow-up report will be provided upon conclusion of investigation.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.H3 other text : device not returned.
Event or Problem Description
The boot covers have a black strip on the bottom that comes off.The strip helps prevent slipping while walking in the boot covers.Staff are worried about potentially falling and injurying themselves or patients while wearing these in an or setting where fluids are present.There are no injuries reported currently by the site.
Additional Manufacturer Narrative
The below corrective and preventative actions were implemented by supplier since april 26th, 2023, as a result of prior similar complaint.There was no lot number or samples received by the complainant, therefore, o&m is not sure if the complaint product was manufactured before or after these corrective actions were implemented.The manufacturing site has taken the following actions: 1.Updated the work instruction to add requirements and visual photo instructions for sticking the foam strips.2.Informed workers about the customer complaint to increase awareness.3.Increased inspection frequency of the pasting process from twice a day to four times a day.4.Created a folding diagram.5.Retrained teammates on new work instructions and diagram.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: HG FULL BOOT COVER
• 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: 19469310
• Report Number: 3014421917-2024-00016
• Device Sequence Number: 16998692
• Product Code: LYU
• UDI-Device Identifier: 30680651696725
• UDI-Public: 30680651696725
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/17/2024

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: 69672
• Device Catalogue Number: 991069672
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/17/2024
• 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