MAUDE Adverse Event Report: O&M HALYARD, INC. AERO CHROME* BREATHABLE PERFORMANCE SURGICAL GOWN WITH TOWEL- XLARGE-STERILE; SURGICAL GOWNS

Model Number 44674

Device Problem Compatibility Problem (2960)

Patient Problem Rash (2033)

Event Type  Injury  

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 (b)(4), 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.

Event 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 # (b)(4)) and the aero chrome breathable performance surgical gown (ref # (b)(4)).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 teatments not specified.

Manufacturer Narrative

The product involved in the event was not returned for evaluation.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: notification of the reported incident was sent to the gown's manufacturing area.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.H3 other text: device not returned.

• Type of Device: 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: 17736688
• MDR Text Key: 323294633
• Report Number: 9680646-2023-00002
• Device Sequence Number: 1
• Product Code: KYA
• UDI-Device Identifier: 30680651446740
• UDI-Public: 30680651446740
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 44674
• Device Catalogue Number: 104467400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male