MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE,PLASTC,CURAD,60CT,3/4X3"

Catalog Number	CUR45153RB
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the adhesive on the bandaide was to strong.When she took the badage off it left a bruise on upper inner left arm.It didn't rip her skin however it was really hard to get off.".
Additional Manufacturer Narrative
The customer reported the adhesive on the bandage was too strong, it left a bruise on the upper inner left arm when she took the bandage off, it did not rip her skin, and it was really hard to get off.At this time no sample has been received for this complaint after reaching out to the customer requesting additional information, and medline evaluated 6 months of complaint history for this item and had similar complaints reported for this issue.Without a physical sample or picture, it could not be established that the root cause was directly related to the manufacture of the product, and at this time medline cannot confirm a quality issue with the product based off the information received.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,PLASTC,CURAD,60CT,3/4X3"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50714519
• Report Number: 1417592-2026-35720
• Device Sequence Number: 10599201
• Product Code: KGX
• UDI-Device Identifier: 40080196302858
• UDI-Public: 40080196302858
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/05/2026

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: CUR45153RB
• Device Lot Number: 210803
• 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: 05/17/2023
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown