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

Model Number	41726
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	Rash (2033)
Type of Reportable Event	Serious Injury
Event or Problem Description
Dermatologist reports that his patient has a suspected allergy to an ingredient in sleeve and collar portion of surgical gowns.The patient utilizes aero blue performance surgical gown (ref # 41726) and the aero chrome breathable performance surgical gown (ref # 44674).Patient has a history of allergic contact dermatitis to several allergens, including carba mix in surgical gloves.Patient presents with rash on hands and central neck, that worsens after surgical days.These areas are touched by the cuff and neckline of the surgical gowns.Patient receives topical prescription steroids and other treatments not specified.
Additional Manufacturer Narrative
The product involved in the event was not returned.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.
Additional Manufacturer Narrative
The product involved in the event was not returned for evalation.The investigation was performed per information provided by the customer.A sample, photo or lot number was not available to perform an evaluation.We were unable to review the device history record for this complaint given the reporter did not provide a complaint lot number.We reached out to the customer for additional information on august 15, 18, and 24th to obtain additional details.The reporter has not responded.The safety clearance assessment of the aero blue surgical gown was reviewed and confirmed that the gown is not considered to be an irritant.Based on the information available and investigation performed, a root cause was not identified.Actions taken: 1.Notification of the reported incident was sent to the gown's manufacturing area.2.Complaint data is monitored to identify upward trends associated with the reported incident/family.A review of the manufacturing area's cleaning process was performed and there have been no changes.Per procedure, the working stations are cleaned at the beginning of each shift.The 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.

• Common Device Name: SURGICAL GOWNS
• 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: 17736727
• Report Number: 9680646-2023-00003
• Device Sequence Number: 12446609
• Product Code: FYA
• UDI-Device Identifier: 30680651417269
• UDI-Public: 30680651417269
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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: 41726
• Device Catalogue Number: 104172601
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 11/15/2023
• 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: Male