MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BANDAGE,GAUZE,CONFORMING,6"X80",STRL,LF

Catalog Number	NON25499
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the gauze quality has changed and they do not stay on the leg.It does not conform and feels very tight when on her leg.It feels like you have tight strings on you.".
Additional Manufacturer Narrative
The customer explained that the gauze quality has changed, they do not stay on the leg, it does not conform, and feels very tight when on her leg.At this time, a sample was not received for this complaint, and without a physical sample or picture, this limits the ability to investigate the issue thoroughly; 6 months of complaints for this product were evaluated and no similar complaints for this issue were found.Due to this, the complaint was not confirmed, and the cause code states sample required to determine cause.A closing response has been disclosed 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: MEDLINE
• Common Device Name: BANDAGE,GAUZE,CONFORMING,6"X80",STRL,LF
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sasidhar lakku ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50900367
• Report Number: 1417592-2026-51265
• Device Sequence Number: 12219666
• Product Code: FQM
• UDI-Device Identifier: 40080196692492
• UDI-Public: 40080196692492
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 09/24/2026

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: NON25499
• Device Lot Number: 6052308001
• 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: 11/01/2023
• Initial Report FDA Received Date: 09/25/2026
• 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
• Patient Weight: 1 LB