MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP CURAD; STRIP,CLOSURE,WOUND,MEDI-STRIP,1/4X1.5

Catalog Number	NON250114
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Caustic/Chemical Burns (2549); Skin Inflammation/ Irritation (4545)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, the wound closure strip caused "redness" where the bandage was in contact with the skin.The customer stated that the area caused "severe itching".
Additional Manufacturer Narrative
According to the customer, the wound closure strip caused "redness" where the bandage was in contact with the skin.The customer stated that the area caused "severe itching".The customer reported he applied "steroid creams and antihistamine sprays" without resolve.The customer reported he went to the emergency room to seek treatment.The customer reported the emergency room physician prescribed him a "stronger steroid", and his physician prescribed him an "ointment for chemical burns" at a follow up appointment.The customer reported the area is now beginning to "heal" after utilizing the prescriptions.The customer reported there was no serious injury, medical intervention, or follow-up care related to the reported incident.No additional details are available related to the customer reported issue.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.

• Brand Name: CURAD
• Common Device Name: STRIP,CLOSURE,WOUND,MEDI-STRIP,1/4X1.5
• 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: 23658509
• Report Number: 1417592-2025-00660
• Device Sequence Number: 21363183
• Product Code: KGX
• UDI-Device Identifier: 20080196691705
• UDI-Public: 20080196691705
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/26/2025

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: Lay User/Patient
• Device Catalogue Number: NON250114
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/26/2025
• 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 Sex: Male