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

Model Number	41734
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident three of three the product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of the 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
Incident three an employee was reported to have an issue with wearing halyard gown since july 2024.The employee developed a rash on forearms, hands and inner elbow area.The employee has been seen by employee health multiple times where they were provided topical medication and advised to wear alternate gown.
Additional Manufacturer Narrative
Incident three of three.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.Based on the investigation, the absence of a lot number prevented tracing the product to a specific manufacturing lot and conducting a device history record review.The safety clearance assessment for aero blue surgical gowns confirmed the product is non-irritating.Primary skin: the test article extracts were considered negligible irritants.Cytotoxicity: the test article meets the requirements of the test and is not considered to have a cytotoxic potential.Sensitization: the test article extracts were considered negligible irritants.A review of the manufacturing area's cleaning process was performed, there have been no changes.Per procedure, the assembly stations are cleaned at the beginning of each shift and when there is a line clearance.Complaint data was reviewed from february 2024 to january 2025.There have been two complaints reported for adverse events for the aero blue surgical gowns.Based on current complaint analysis, there are 0.12 complaints per million aero blue surgical gowns.No specific root cause was identified.The manufacturing area was notified of the incident.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
• 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: 21329023
• Report Number: 9680646-2025-00003
• Device Sequence Number: 7918292
• Product Code: FYA
• UDI-Device Identifier: 30680651417344
• UDI-Public: 30680651417344
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 03/07/2025

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: 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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/07/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown