MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; GOWN,SIRUS,POLYRNF,BRTHSLV,XLN/XXL,18/CS

Catalog Number	DYNJP2229S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Rash (2033)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the surgeon developed a "rash" that is "aggravated by repeated exposure" to the gowns that began on (b)(6) 2024, and it "appears to relate to the cuff".
Additional Manufacturer Narrative
According to the customer, the surgeon developed a "rash" that is "aggravated by repeated exposure" to the gowns that began on (b)(6) 2024, and it "appears to relate to the cuff".The customer reported "medical intervention was necessary to treat the skin rash", and the surgeon is consulting a dermatologist.The customer reported the "skin condition resolves within 1 week of not doing surgery".The customer did not report any serious injury related to the reported event.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Reported lot numbers: 11021100147, 20824080014k, 20824100035k.Manufacturing dates related to the reported lot numbers: oct-21, aug-24, and oct-24.
Additional Manufacturer Narrative
Update to a1: patient identifier.Update to d2a: common device name.Update to d4: catalog number.Update to d4: primary unique device identifier (udi) number.In addition, medline would like to correct the lot numbers and associated manufacturing dates.Please see the corrections below: lot number: 20824100075k: manufacturing date: 10/2024.Lot number: 31124040100e: manufacturing date: 04/2024.

• Common Device Name: GOWN,SIRUS,POLYRNF,BRTHSLV,XLN/XXL,18/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 21979148
• Report Number: 1417592-2025-00214
• Device Sequence Number: 8899146
• Product Code: FYA
• UDI-Device Identifier: 10884389103272
• UDI-Public: 10884389103272
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJP2229S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 90 KG