MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DRAPE,UTILITY,TAPE,15X26",ST,200/CS

Catalog Number	DYNJP2405
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Rash (2033)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient developed a rash to her chest, arms, flanks, and across her lower ribcage area after coming into contact with the adhesive on surgical drapes during a procedure.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
It was reported that the patient developed a rash to her chest, arms, flanks, and across her lower ribcage area after coming into contact with the adhesive on surgical drapes during a procedure.

• Common Device Name: DRAPE,UTILITY,TAPE,15X26",ST,200/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 22929792
• Report Number: 1417592-2025-00436
• Device Sequence Number: 13319684
• Product Code: PUI
• UDI-Device Identifier: 00080196730837
• UDI-Public: 00080196730837
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 08/29/2025

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: DYNJP2405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 09/02/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 49 KG