MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; PATEWOOD T AND A PACK

Model Number	DYNJ51727B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2023, a patient was burned on the lip during a tonsillectomy due to exposed metal at the base.After the burn occurred, use of the device was stopped.It was reported that follow up care was provided and the patient required a follow up appointment with a plastic surgeon due to the reported burn.The customer reported the procedure was completed.It was also reported that the patient was readmitted to the hospital on two occasions after the procedure.No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer contact, on (b)(6) 2023, a patient was burned on the lip during a tonsillectomy due to exposed metal at the base.

• Brand Name: Medline Industries, Inc.
• Common Device Name: PATEWOOD T AND A PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17170427
• Report Number: 1423395-2023-00029
• Device Sequence Number: 6593604
• Product Code: OGR
• UDI-Device Identifier: 10195327369767
• UDI-Public: 10195327369767
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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?: No
• Device Model Number: DYNJ51727B
• Device Catalogue Number: DYNJ51727B
• Device Lot Number: 23CBW190
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown