MAUDE Adverse Event Report: Medline Industries, LP CURAD; DBD-BNDG,ANTIBAC,IRONMAN,1X3.25,6-CLRS,2

Catalog Number	CURIM5020V1H
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ulcer (2274); Skin Tears (2516); Blister (4537)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction

• Brand Name: CURAD
• Common Device Name: DBD-BNDG,ANTIBAC,IRONMAN,1X3.25,6-CLRS,2
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azra halilovic ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50698543
• Report Number: 1417592-2026-35371
• Device Sequence Number: 18540707
• Product Code: FRO
• UDI-Device Identifier: 00193489023469
• UDI-Public: 00193489023469
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K113583
• 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): 09/09/2026

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: CURIM5020V1H
• Device Lot Number: 230701
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2024
• 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: 12/06/2023
• Initial Report FDA Received Date: 09/09/2026
• 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 Sex: Unknown