MAUDE Adverse Event Report: Medline Industries, LP CURAD; BANDAGE, PLASTIC,CURAD,2"X4",10CT

Catalog Number	CUR47437RBH
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	12/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "i was involved with several problems, due to the product's very strong glue.".
Additional Manufacturer Narrative
The customer reported that the bandages caused a reaction to the skin resulting in blistering and tearing of the skin, and later stated he was unable to work for several days and still had a visible mark on his skin.Photos of the injury site and the single bandage used were observed, a single used bandage was provided by the customer, the vendor was notified of the reported issue, and the vendor provided a coa for the product from this lot.Based on the information provided by the customer, the sample, and the coa provided by the vendor, medline was unable to confirm a defect with this product that could have contributed to the customer's allergic reaction.The complaint was classified as defect confirmed - traced to user, attributed to an individual allergic response rather than a product manufacturing or quality defect, 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: CURAD
• Common Device Name: BANDAGE, PLASTIC,CURAD,2"X4",10CT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: konstantina callas ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50803356
• Report Number: 1417592-2026-43459
• Device Sequence Number: 10610508
• Product Code: KGX
• UDI-Device Identifier: 00080196303048
• UDI-Public: 00080196303048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/11/2026

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: CUR47437RBH
• Device Lot Number: 90922110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/29/2024
• 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: 12/12/2023
• Initial Report FDA Received Date: 09/17/2026
• 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: Male