MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BNDG,ANTIBAC,,FNG/KNK,6-CLR,20CT

Catalog Number	CURIM5021V1
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Biocompatibility (2886)
Health Effect - Clinical Codes	Scar Tissue (2060); Skin Tears (2516); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: BNDG,ANTIBAC,,FNG/KNK,6-CLR,20CT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: rizwan shaik ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50847089
• Report Number: 1417592-2026-47060
• Device Sequence Number: 21245466
• Product Code: FRO
• UDI-Device Identifier: 20193489023470
• UDI-Public: 20193489023470
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 09/04/2026

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: CURIM5021V1
• Device Lot Number: (10) 220401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/06/2023
• 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: 04/19/2023
• Initial Report FDA Received Date: 09/21/2026
• 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