MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN XL; SURGICAL GOWNS STERILE

Model Number	41734
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was returned and pending evaluation.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 comp (b)(4).This information is submitted pursuant to 21cfr803 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
A strong chemical smell was reported by the customer coming from the halyard aero blue performance surgical gown, xl.One staff member required medical evaluation; treatment details remain unknown.The smell appears to be limited to the gown and lot.The entire lot associated with this gown has been quarantined by the customer.On (b)(6) 2024, a response was received from the customer that states there was no delay in surgical or emergency procedures.The product was shipped to (b)(6) clinic by a distributor.
Additional Manufacturer Narrative
One product case was opened in the lab and all thirty (30) product packages were opened.A subjective olfactory assessment was performed on these samples.No odor was detected apart from what was described as standard plastic smell from nonwovens.One week later, the thirty (30) product packages were removed from the same open case and a subjective olfactory assessment was performed.There was an odor detected on some of the already open product packages.The odor detected can be described as a musty or moldy odor.Others in the office performed a subjective olfactory assessment on these same samples.The odor detected was offensive to some and was described as musty or moldy.The second case of product was opened in the lab.Two (2) gown packages were opened.Subjective olfactory assessment found odor presence described as moldy or musty.The device history records were reviewed and confirmed product was manufactured and released per specifications.Eo and ech (ethylene chlorohydrin) values are below the ansi/aami iso 10993-7 requirement and product requirements.Based on these results, eo and ech residuals did not likely contribute to the odor.Gas chromatography/mass spectrometry (gcms) with thermal desorption testing was performed at room temperature and also at increased temperature by a third-party testing laboratory.The test identified two potential chemicals which could cause potential odors (galaxolide and alpha hexylcinnamyl aldehyde).O&m has determined these were not the likely source of odor.No root cause was identified.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 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: HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN XL
• Common Device Name: SURGICAL GOWNS STERILE
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; alpharetta GA 30005
• Manufacturer (Section G): O&M HALYARD HONDURAS S.A DE C.V.; carretera tegucigalpa; villaneva cortes, hn ; HO
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 20567440
• Report Number: 9680646-2024-00010
• Device Sequence Number: 7532198
• Product Code: FYA
• UDI-Device Identifier: 30680651417344
• UDI-Public: 30680651417344
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192362
• 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): 02/17/2025

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: 41734
• Device Catalogue Number: 41734
• Device Lot Number: AH4217TU6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/18/2025
• 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