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

Catalog Number	PRM25500
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	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bandage "didnt stay on once applied" and "bandages are not sticky.".
Additional Manufacturer Narrative
The customer reported that the bandage "didnt stay on once applied" and "bandages are not sticky"; it was "applied to the arm after a blood draw," and no allergic reaction or skin irritation was reported.A sample was not received, and without a physical sample or picture, this limited medline's ability to investigate the issue thoroughly and establish a root cause; medline evaluated 6 months of complaint history for this product and had no other complaints regarding this issue.Due to this, the complaint was not confirmed, and a root cause for the reported defect was not established.Medline concluded this was an isolated incident, disclosed a closing response, 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: BANDAGE,ADHESIVE,PLASTIC,3/4"X3",ST,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50732189
• Report Number: 1417592-2026-36786
• Device Sequence Number: 10633026
• Product Code: KGX
• UDI-Device Identifier: 40080196754619
• UDI-Public: 40080196754619
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: PRM25500
• Device Lot Number: 230601
• 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: 09/22/2023
• Initial Report FDA Received Date: 09/11/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown