MAUDE Adverse Event Report: Medline Industries, LP CURAD; BANDAGE,CURAD,CLEAR,STRP,1"X2.5",30EA/BX

Catalog Number	CUR00005RB
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "box states it is waterproof, and it is not sticking to skin meaning it is not waterproof.".
Additional Manufacturer Narrative
A complaint was received related to weak adhesion from waterproof bandages; the customer reported that the box states it is waterproof and it is not sticking to skin meaning it is not waterproof, and reported no allergic reaction or skin irritation.The provided sample was evaluated, the vendor was notified of the issue, and trend analysis was performed by reviewing the past two years of complaint data; the received bandages were visually inspected and were able to adhere to a clean, dry surface as intended for several hours and did not show signs of weak adhesion such as peeling.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 the vendor noted that there were no indications of potential causes to the reported issue.A review of the complaint information as well as the results of the investigation indicated no need for further action at this time, and complaints are monitored via the trend analysis procedure.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,CURAD,CLEAR,STRP,1"X2.5",30EA/BX
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50754692
• Report Number: 1417592-2026-39270
• Device Sequence Number: 9241074
• Product Code: KGX
• UDI-Device Identifier: 00884389108270
• UDI-Public: 00884389108270
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/09/2026

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: CUR00005RB
• Device Lot Number: 211202
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2025
• 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: 08/29/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown