MAUDE Adverse Event Report: Medline Industries, LP CURAD; TAPE,ELASTIC,FOAM,CURAD,3X5.5YD,LF,24/C

Catalog Number	NON270603
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Skin Tears (2516); Blister (4537)
Date of Event	01/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician went to take the tape off the patients and while taking the tape off, it caused skin tears.
Additional Manufacturer Narrative
A complaint was received related to skin tears caused by removal of elastic foam tape; the customer also reported that the product was used to apply pressure on a c-section incision by holding a blue towel over a sterile dressing, and when the dressing was removed at 12 hrs, staff noticed blisters where the foam tape touched the patient¿s skin.The provided samples were evaluated, the vendor was notified, and trend analysis was performed; visual inspection of the tape did not note any visual defects, and the tape adhered to a clean, dry surface for several hours and was removed without signs of aggressive adhesion, adhesive residue, excessive stretching, or tearing.The vendor¿s review of the production process, relevant records, and retained samples noted no indications of potential causes; peel strength testing met conformance and a skin pasting test did not replicate the reported issue upon removal.Based on the information provided and the results of the investigation, medline is not able to confirm the reported issue or that the product failed to meet specifications.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CURAD
• Common Device Name: TAPE,ELASTIC,FOAM,CURAD,3X5.5YD,LF,24/C
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50932071
• Report Number: 1417592-2026-53015
• Device Sequence Number: 13159045
• Product Code: KGX
• UDI-Device Identifier: 10197344099023
• UDI-Public: 10197344099023
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: NON270603
• Device Lot Number: 84325082603-L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 152 LB
• Patient Race: White