MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; CHS LARGE BASIN PACK

Model Number	DYNJCHSB10
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility during a procedure the bovie tip 'arced' and the patient was burned and required stitches on their lip.
Additional Manufacturer Narrative
According to the facility during a procedure the bovie tip 'arced' and the patient was burned and required stitches on their lip.The sample was returned and a thorough evaluation was performed.A definitive root cause could not be determined.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: Medline Industries, Inc.
• Common Device Name: CHS LARGE BASIN 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: 14138339
• Report Number: 1423395-2022-00012
• Device Sequence Number: 6254190
• Product Code: LRO
• UDI-Device Identifier: 10888277538931
• UDI-Public: 10888277538931
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/23/2022

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: DYNJCHSB10
• Device Catalogue Number: DYNJCHSB10
• Device Lot Number: 22BDA560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female