MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE,ADHESIVE,FABRIC,3/4"X3",STRL,LF

Catalog Number	NON25650Z
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this product quaity is thinner and less sticky.Texture is completley differnt than any other box bought.".
Additional Manufacturer Narrative
The customer reported that the product quality is "thinner and less sticky" and the "texture is completley differnt than any other box bought"; the customer also reported no allergic reaction or skin irritation and that the bandage was applied to the finger.No physical or photo samples of the complaint item or issue were provided by the customer for review and the vendor was notified; based on the vendor's response, nothing was found within any relevant records to indicate any potential contributors, and trending over the past two years found no other complaints with this product regarding this issue.Based on the information provided and the results of the investigation, medline was not able to confirm the reported issue or that the product failed to meet specifications; the cause was unconfirmed/sample required to determine cause.No corrective or preventative actions were implemented, and complaints will continue to be monitored via the trend analysis procedure.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: BANDAGE,ADHESIVE,FABRIC,3/4"X3",STRL,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50794044
• Report Number: 1417592-2026-42917
• Device Sequence Number: 9443251
• Product Code: KGX
• UDI-Device Identifier: 10080196734696
• UDI-Public: 10080196734696
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/15/2026

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: NON25650Z
• Device Lot Number: 241104
• 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: 04/25/2025
• 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: Unknown