MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CURAD,BANDAGES,ASST,320CT/BX-CASE

Catalog Number	CURCC320BC
Medical Device Problem Code	Adhesive Too Strong (4071)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Erythema (1840)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i purchased this bulk pack and used a bandage which caused severe bruising to my arm after being on small cut for less than 8 hours" and "the adhesive was so strong that it created a bruise 10 times the original cut and i used a small bandage maybe 3/4\" x 3\".".
Additional Manufacturer Narrative
A complaint was received related to aggressive adhesion from bandages; the customer reported the adhesive was so strong that it created a bruise 10 times the original cut, and bruising and redness could be seen on the skin where the bandage was applied.The provided photos were reviewed, the vendor was notified of the issue, trend analysis was performed by reviewing the past two years of complaint data, and the vendor reviewed the production process, relevant records, and retained samples from the product lot.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, and no root cause was identified.The coa was reviewed and it was determined that the product lot met all technical requirements including adhesive strength; complaints are monitored via the trend analysis procedure.There were no reports of death, serious injury, medical intervention, or follow up care.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: CURAD,BANDAGES,ASST,320CT/BX-CASE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50852590
• Report Number: 1417592-2026-47255
• Device Sequence Number: 9651871
• Product Code: KGX
• UDI-Device Identifier: 00888277362966
• UDI-Public: 00888277362966
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/21/2026

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: CURCC320BC
• Device Lot Number: 240905
• 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: 09/12/2025
• Initial Report FDA Received Date: 09/22/2026
• 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: Male