MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-BANDAGE,SENSITIVE SKIN,3/4"X3",30/BX

Catalog Number	CUR45227NRB
Medical Device Problem Codes	Biocompatibility (2886); Adhesive Too Strong (4071)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, per customer, "it was stuck so tightly to my skin that i had difficulty pulling it off.When i finally was able to remove the bandage it had left a bruise where the sticky part was on my skin.".
Additional Manufacturer Narrative
According to the customer, after having a mole removed from their thigh they applied a sensitive skin bandage to the open sore, and when attempting to remove the bandage from their skin the following day, they found that it was "stuck to their skin" and noticed a bruise in the area the adhesive portion of the bandage was located.A sample of the product was provided by the customer in a used condition, and from the samples received medline was unable to confirm the issue reported.It could not be established that the root cause was directly related to the manufacture of the product.At this time medline cannot confirm a quality issue with the product based off the information received, 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: DBD-BANDAGE,SENSITIVE SKIN,3/4"X3",30/BX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50884923
• Report Number: 1417592-2026-50096
• Device Sequence Number: 10755101
• Product Code: KGX
• UDI-Device Identifier: 40080196302612
• UDI-Public: 40080196302612
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 09/23/2026

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: CUR45227NRB
• Device Lot Number: 16061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/09/2023
• 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: 05/02/2023
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (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