MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; STICKRIGHT, 6" X 2 YD

Catalog Number	MSC4226EP
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2026, upon removal of the tape the patient experienced a "burning sensation, blister formation, and/or skin tearing".No additional details are available related to the customer reported issue.There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
According to the customer, on (b)(6) 2026, upon removal of the tape the patient experienced a "burning sensation, blister formation, and/or skin tearing".No additional details are available related to the customer reported issue.

• Brand Name: MEDLINE
• Common Device Name: STICKRIGHT, 6" X 2 YD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25670057
• Report Number: 1417592-2026-03725
• Device Sequence Number: 18743543
• Product Code: KGX
• UDI-Device Identifier: 10197344102785
• UDI-Public: 10197344102785
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MSC4226EP
• Device Lot Number: 87525120050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2025
• 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: 36 YR
• Patient Sex: Female
• Patient Weight: 61 KG