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

Catalog Number	MSC4226EP
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Burning Sensation (2146); Skin Tears (2516); Blister (4537)
Date of Event	04/06/2026
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".The customer reported that the patient required a wound care consult to manage the injury and "and one home wound care treatment".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".The customer reported that the patient required a wound care consult to manage the injury and "and one home wound care treatment".

• Brand Name: MEDLINE
• Common Device Name: STICKRIGHT, 6" X 2 YD
• 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: 25670272
• Report Number: 1417592-2026-03719
• Device Sequence Number: 5596985
• 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,Followup
• Report Date (Section B): 07/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MSC4226EP
• Device Lot Number: 87525120050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 07/08/2026
• 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: 31 YR
• Patient Sex: Female
• Patient Weight: 108 KG