MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-KDOP ENT PACK

Catalog Number	DYNJ37144C
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on (b)(6) 2023 during an adenoidectomy the surgeon noticed that the outer cheek looked burn and noted insulation on instrument had \" burned off\" at the bend, noted burn to tongue and inside cheek".
Additional Manufacturer Narrative
The customer contact reported that during an adenoidectomy the surgeon noticed that the outer cheek looked burn and noted insulation on instrument had "burned off" at the bend, noted burn to tongue and inside cheek.Medline reviewed the finished good production records, finished good pack build, account complaint history, and component complaint history; no sample or photo was received for the investigation.The defect could not be confirmed as no samples or detailed pictures were received for this complaint investigation.Without a sample it is difficult to determine a true root cause for the reported issue; the complaint was provided to the vendor for further evaluation and supplier quality will monitor this issue for trending purposes.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: DBD-KDOP ENT PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranay abbu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50746279
• Report Number: 1417592-2026-38149
• Device Sequence Number: 10235750
• Product Code: OGR
• UDI-Device Identifier: 40193489275323
• UDI-Public: 40193489275323
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: DYNJ37144C
• Device Lot Number: 23CBU592
• 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: 08/23/2023
• Initial Report FDA Received Date: 09/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown