MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS

Catalog Number	DYNJP2402
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033); Skin Burning Sensation (4540); Swelling/ Edema (4577)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, gown caused skin reaction.Per the facility, "gown was on for an hour.Itching and burning noted after 30 minutes.Red raised rash around where gown cuffs were in contact with skin." the facility reported the skin irritation resolved with "washing of the skin and administration of dexamethasone." the individual is doing "fine." no additional information at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, gown caused skin reaction.Per the facility, "gown was on for an hour.Itching and burning noted after 30 minutes.Red raised rash around where gown cuffs were in contact with skin." the facility reported the skin irritation resolved with "washing of the skin and administration of dexamethasone." the individual is doing "fine.".

• Common Device Name: GOWN,SIRUS,NONRNF,RAGLAN,XL,ST,30/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23606042
• Report Number: 1417592-2025-00645
• Device Sequence Number: 21326627
• Product Code: FYA
• UDI-Device Identifier: 10080196744718
• UDI-Public: 10080196744718
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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
• Device Catalogue Number: DYNJP2402
• Device Lot Number: 11025080208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 58 KG