MAUDE Adverse Event Report: Medline Industries, LP CURAD; PAD,GAUZE,2"X2",25CT

Catalog Number	CUR20423RBIH
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the small gauze stuck to wound.
Additional Manufacturer Narrative
The customer reported that the small gauze pads has stuck to wound; no sample or photos were received for this complaint; without a physical sample or picture, this limits the ability to investigate the issue thoroughly, and analysis of complaint data over the past two years determined that there were no other complaints regarding this product sticking to a wound.At this time medline cannot confirm based off the information received, and the cause was documented as "sample required to determine cause." due diligence was completed and no additional details are available.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: PAD,GAUZE,2"X2",25CT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: herchelle teodoro ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50752704
• Report Number: 1417592-2026-38988
• Device Sequence Number: 18451817
• Product Code: NAB
• UDI-Device Identifier: 00080196305059
• UDI-Public: 00080196305059
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/14/2026

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: CUR20423RBIH
• Device Lot Number: 605230914
• 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: 09/27/2024
• Initial Report FDA Received Date: 09/14/2026
• 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: Unknown