MAUDE Adverse Event Report: Medline Industries, LP CURAD; BANDAGE,BUTTERFLY,WP,CURAD,1 3/4"X3/8"

Catalog Number	CUR47442RBZ
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction

• Brand Name: CURAD
• Common Device Name: BANDAGE,BUTTERFLY,WP,CURAD,1 3/4"X3/8"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: abdul khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50793515
• Report Number: 1417592-2026-42800
• Device Sequence Number: 9607559
• Product Code: KGX
• UDI-Device Identifier: 00080196320830
• UDI-Public: 00080196320830
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/08/2026

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: CUR47442RBZ
• Device Lot Number: 120A171
• 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: 03/09/2026
• Initial Report FDA Received Date: 09/16/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male