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

Model Number	69600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in this complaint is 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 a o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.
Event or Problem Description
Customer is dissatisfied with gown performance.Customer states they have used gown for 15 years and quality has decreased.Customer states the gown becomes wet when she leans against sink.The customer reported in 2018 a co-worker experienced chemical burns on their arms during use of the gown when enzymatic fluid soaked through the gown.The co-worker went to the physician multiple times for treatment.The exact event date and further details are unknown.There was no hospital stay or surgical intervention performed.
Additional Manufacturer Narrative
The product involved in this complaint was not available for evaluation.A quality nonconformance was not reported during lot manufacture.Visual and functional inspections are performed for each lot based on statistical sampling.Complaint trend was reviewed for code 69600 for strike through failure mode.There is no upward trend detected during the past 12 months.A root cause was not identified.Notification of this incident was sent to manufacturing leaders for awareness.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.H3 other text: device not returned.

• 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: 18895839
• Report Number: 9616096-2024-00002
• Device Sequence Number: 12294761
• Product Code: OEA
• UDI-Device Identifier: 30680651696008
• UDI-Public: 30680651696008
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Consumer,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: 69600
• Device Catalogue Number: 106960067
• Device Lot Number: AM23292921
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• 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