MAUDE Adverse Event Report: Medline Industries, LP PRIVATE LABELED FOR CUSTOMER; DBD-WRX,BANDAGE,ADHESIVE,200CT.ASSTD

Catalog Number	WRX931979V1
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "she was unable to get the bandaid off.".
Additional Manufacturer Narrative
According to the customer, on 11/14/23 the customer placed a bandage on her finger to cover a burn that occurred previously, attempted to remove the bandage after an unspecified amount of time and incurred some difficulty in removing the bandage; after removing the bandage their skin was red and irritated, and the customer did not require medical attention related to the reported event.At this time, a sample was not received for this complaint, and without a physical sample or picture, this limits our ability to investigate the issue thoroughly and establish a root cause for the reported defect; 6 months of complaint history for this product had no similar complaints.Due to this, the complaint was not confirmed, and the cause was listed as sample required to determine cause.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: PRIVATE LABELED FOR CUSTOMER
• Common Device Name: DBD-WRX,BANDAGE,ADHESIVE,200CT.ASSTD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804569
• Report Number: 1417592-2026-43691
• Device Sequence Number: 18789044
• Product Code: KGX
• UDI-Device Identifier: 10311917182701
• UDI-Public: 10311917182701
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/16/2026

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: WRX931979V1
• Device Lot Number: 210604
• 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: 11/17/2023
• Initial Report FDA Received Date: 09/17/2026
• 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: Female