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

Model Number	69572
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Fall (1848)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Initial complaint was received on october 9th, 2023, indicating there was a concern about lack of traction on the shoe covers.There was no injury or adverse effects reported at that time, leading to an initial determination that this would not be reportable or likely cause a serious injury should it recur.Owens and minor received a request to return product on may 6th, 2024.During this communication, it was indicated by the reporter, that there was a "slip" that had occurred.Owens and minor followed up with the reporter to obtain additional incident details.The reporter now indicates that the surgical assistant had fallen and hurt back.No intervention or medical treatment was required.
Additional Manufacturer Narrative
A box of shoe covers was received from customer, there was a confirmed folding problem noted which likely resulted in uneven foam strips.O&m halyard, inc.Is the specification developer and complaint handling establishment of the complaint product.The product is contract manufactured by (b)(6); (fda registration number (b)(4).A scar was issued to the contract manufacturer on october 13, 2023.During the folding and packaging process, one worker did not smooth and squeeze the foam strip.Then the folding and packaging workers folded the product, which resulted in the warping of the edges of some foam strips.The issue remained undetected during final inspection processes.The contract manufacturer has implemented the following corrective actions as a result of this complaint.1 updated the work instruction to add pictures for sticking the foam strips.2 retrained the workers to updated work instruction.The operators were informed about the customer complaint to increase quality awareness.3 increased the inspection frequency.4.Updated work instructions and retrained the folding workers.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.

• Brand Name: HG FULL CVR BOOT UNIV
• 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: 19451008
• Report Number: 3014421917-2024-00014
• Device Sequence Number: 8538193
• Product Code: LYU
• UDI-Device Identifier: 30680651695728
• UDI-Public: 30680651695728
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 69572
• Device Catalogue Number: 991069572
• Device Lot Number: HX23036027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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
• Initial Report FDA Received Date: 06/03/2024
• 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: Male