MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CURAD,BANDAGES,ASST,18 BX/CS, NO TRAY

Catalog Number	CURCC300NT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, when the user removed the bandage on their left inner bicep, "it took a decent sized piece of skin with it," and per the customer there is "scabbing there now"; no medical intervention, serious injury, or follow-up care has been reported.No physical samples of curcc300nt were received, however photos of the complaint issue were provided by the customer; the photo of the injury was reviewed in addition to the clinical product surveillance response, the vendor was notified, and the coa was requested and reviewed.Upon review of the coa, this product was manufactured to specification, and the reported issue was not confirmed to be related to the manufacturing of this product.No confirmed root cause was identified; a closing response was disclosed and the divisional quality representative will continue to monitor this issue for tracking and trending purposes during quarterly trending.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.
Event or Problem Description
It was reported that "i used a bandaid of yours the other day and when taking it off it actully tore a piece of skin off with it.".

• Brand Name: MEDLINE
• Common Device Name: CURAD,BANDAGES,ASST,18 BX/CS, NO TRAY
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50771662
• Report Number: 1417592-2026-40328
• Device Sequence Number: 10445874
• Product Code: KGX
• UDI-Device Identifier: 00888277420031
• UDI-Public: 00888277420031
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/07/2026

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: CURCC300NT
• Device Lot Number: 240301
• Was Device Available for Evaluation?: Yes
• 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: 09/24/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 175 LB