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

Catalog Number	CURIM5021V1
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bandages do not stick.
Additional Manufacturer Narrative
This is a combination product per customer, the bandages do not stick.At this time no sample has been received for this complaint, and without a physical sample or picture, it could not be established that the root cause was directly related to the manufacture of the product; medline evaluated 6 months of complaint history for this item and had no similar complaints reported for this issue.At this time medline cannot confirm a quality issue with the product based off the information received, and the cause was documented as sample required to determine cause.This issue reported would not be considered a trending issue, 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.

• 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: rahul kota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50777925
• Report Number: 1417592-2026-41223
• Device Sequence Number: 16122953
• Product Code: FRO
• UDI-Device Identifier: 20193489023470
• UDI-Public: 20193489023470
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 09/15/2026

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: 10221203
• Was Device Available for Evaluation?: No
• 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: 04/04/2023
• 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 Sex: Unknown