MAUDE Adverse Event Report: O&M HALYARD, INC. IMP GWN W/KNITCF UNIV; PROTECTIVE APPAREL

Model Number	69600
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Local Reaction (2035)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not available for evaluation.A follow-up report will be provided upon the conclusion of the 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The customer reported strike through in the middle of the gown.The gowns were used for decontamination, not for use in patient care for this incident.An employee had strike through where the detergent caused a reaction of burning and irritation.Employee went to emergency department and was out of work for 2 days.Employee utilized an otc cream for irritation.
Additional Manufacturer Narrative
A review of device history record was not able to be performed as a lot number was not provided.Biocompatibility testing for the base fabric and other components of the gown with direct human contact shows that the gown is non-sensitizing, non-cytotoxic, and non-irritating to potential patient and end users.A review of complaints was performed and there is no upward trend in the past 12 months for this issue for the complaint product.Notification was sent to manufacturing leaders for awareness purposes.A root cause was not identified.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 an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: IMP GWN W/KNITCF UNIV
• Common Device Name: PROTECTIVE APPAREL
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUÑA S. DE R.L DE C.V.; carretera presa la amistad km; parque industrial amistad; cd. acuña, coahuila mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19726607
• Report Number: 9616096-2024-00003
• Device Sequence Number: 8328419
• Product Code: OEA
• UDI-Device Identifier: 30680651696008
• UDI-Public: 30680651696008
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/04/2024

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: 69600
• Device Catalogue Number: 106960067
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 09/04/2024
• 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