MAUDE Adverse Event Report: O&M HAYARD, INC. SURGICAL ULTRA GOWN LARGE 32; SURGICAL GOWNS

Model Number	95111
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Local Reaction (2035)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was returned for evaluation.One (1) sealed, unused representative sample was received with the product packaging.The sample was evaluated under ambient light conditions.There are no damages observed on the product packaging.The csr wrap was unwrapped and there are no damages observed on the csr wrap.The gown was unfolded for inspection.The tie cards are attached to the ties at the front of the gown as intended.There are no damages observed on the front of the gown.The back and inside of the gown and the seams of the gown were inspected and no damages observed.The knitted cuffs were inspected inside and out.When the sleeves were turned inside out, loose threads are observed at the sewn seams.The threads are tied off after sewing and no gaps are observed.The knitted cuffs are visually different in length.The left cuff measures approximately 3 inches in length and the right cuff measures approximately 3.25 inches in length.The gown was compared to specification component and the specification drawing states the cuffs should measure 3.75 +/-.50 inches.The observation of the difference in cuff size is noted in this evaluation however the size of the cuffs would probably not contribute to a reaction incident.There is nothing visual on the knitted cuffs to confirm the reaction experienced by the customer.The falure analysis lab is unable to confirm the reaction with the evaluation conducted in the lab.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, 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
The customer reported that several staff members, including surgeons were experiencing issues with skin breakdown around their wrist and lower forearm.The staff felt the issue was caused by something in the cuff of the gowns.Per customer, staff member(s) had to schedule appointment with dermatologist and was prescribed steroid rx.There was no loss of work time as a result.
Additional Manufacturer Narrative
A lot number for the gown involved in adverse event was not provided; therefore, a device history record review of the involved gown lot was unable to be performed.Product safety clearance, (b)(6), for ultra surgical gowns was reviewed.The product was not identified as an irritant.Biocompatibility test results for the cuff were reviewed, confirming the material is not an irritant.Environmental results from the prior 12 months were reviewed, including bioburden, surface, and viable/non-viable particles.All results were within specification.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: SURGICAL ULTRA GOWN LARGE 32
• Common Device Name: SURGICAL GOWNS
• Manufacturer (Section D): O&M HAYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): O&M HALYARD HONDURAS S.A DE C..; carretera tegucigalpa; villaneva cortes, hn ; HO
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005
• MDR Report Key: 18837110
• Report Number: 9680646-2024-00001
• Device Sequence Number: 12627094
• Product Code: FYA
• UDI-Device Identifier: 30680651951114
• UDI-Public: 30680651951114
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K080795
• 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): 04/22/2024

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: 95111
• Device Catalogue Number: 991095111
• Device Lot Number: AH3304TC5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/22/2024
• 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