MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; ENT/FESS PACK

Model Number	DYNJ52893C
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received by director of nursing, (b)(6) surgical center.Reporter states, on (b)(6) 2020 a (b)(6), male patient was having a tonsillectomy and adenoidectomy.Reporter states, "bilateral burns created to the corner of the mouth while removing tonsil and adenoids." reporter states, "general anesthesia was used, no additional anesthesia required.Antibiotic ointment applied." reporter states, "the patient is doing well." the sample has been returned for evaluation.Investigation summary (11/23/2020): "the account reported finding bovie tip burned both sides of the mouth.The reported issue occurred in item dynj52893c (lot 20bbt103).Due to the fact that we were able to see charring on the device was are able to confirm the issue but we are not able to determine the root cause of the reported issue." due to the reported nature of the incident and in abundance of caution, this medwatch is filed.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported, "a doctor put the bovie tip in a patient's mouth and burned both side of the mouth.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: ENT/FESS PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10914484
• Report Number: 1423395-2020-00034
• Device Sequence Number: 910360
• Product Code: OGR
• UDI-Device Identifier: 10889942890521
• UDI-Public: 10889942890521
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ52893C
• Device Catalogue Number: DYNJ52893C
• Device Lot Number: 20BBT103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 YR
• Patient Weight: 26