MAUDE Adverse Event Report: Medline Industries, LP Curad; DBD-BANDAGE,WATERPROOF,CURAD,1"X3.25",20

Catalog Number	CUR43021RBV1
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "item is not waterproof.Once she washes her hands the bandaids falls off immediately and does not stay stuck.".
Additional Manufacturer Narrative
The customer stated the item is not waterproof; once she washes her hands the bandages fall off immediately and do not stay stuck, and she used 5 within half a day on her pinky finger.At this time, no physical samples or photos of the product or the complaint issue have been provided by the customer, limiting the ability to investigate thoroughly, and analysis of the past two years of complaint data determined that there was one other unconfirmed complaint with this product regarding this issue.Due to this, the complaint issue could not be confirmed, and the cause was documented as sample required to determine cause.At this time, medline cannot confirm a quality issue with the product based off the information received, 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.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: DBD-BANDAGE,WATERPROOF,CURAD,1"X3.25",20
• 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: 50872635
• Report Number: 1417592-2026-49334
• Device Sequence Number: 16120889
• Product Code: KGX
• UDI-Device Identifier: 00080196320847
• UDI-Public: 00080196320847
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/23/2026

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: CUR43021RBV1
• Device Lot Number: 231001
• 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: 10/21/2024
• Initial Report FDA Received Date: 09/23/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown