MAUDE Adverse Event Report: O&M HALYARD, INC. AREO CHROME BREATHABLE SURGICAL GOWN

Model Number	44678
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported an employee having skin reaction during use of the gown.The event occurred three months ago and the employee experienced a rash on her arm in the sleeve area of the gown.The employee went to her doctor and received steroids and hydrocortisone treatment.No respiratory distress reported.
Additional Manufacturer Narrative
The product involved in the event was not returned for 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 (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.
Additional Manufacturer Narrative
The product safety clearance for aero chrome surgical gowns was reviewed.The primary skin testing confirmed negligible irritants.The cuff testing performed by cuff manufacturer also identified no safety risk associated with the cuff material.Environmental monitoring results (bioburden, surface, and viable/non-viable particle testing) for the last twelve months was reviewed.All results were in specification.No changes have been made to the site cleaning processes.Workstations are cleaned at the beginning of each shift and during lot change.No root cause was identified.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(6) 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.

• Brand Name: AREO CHROME BREATHABLE SURGICAL GOWN
• Common Device Name: SURGICAL GOWN
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): O&M HALYARD HONDURAS S.A DE C.V.; carretera tegucigalpa; villaneva cortes, hn ; HO
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 18895782
• Report Number: 9680646-2024-00004
• Device Sequence Number: 7682413
• Product Code: FYA
• UDI-Device Identifier: 30680651446788
• UDI-Public: 30680651446788
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200522
• 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): 05/07/2024

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: 44678
• Device Catalogue Number: 104467800
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown