MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline Industries, Inc.; LAP PACK

Model Number	DYNJ65158A
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	02/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility a 'protected tip from the cautery came apart while in use and was found in the abdominal cavity'.
Additional Manufacturer Narrative
According to the facility a 'protected tip from the cautery came apart while in use and was found in the abdominal cavity'.No additional details are available.The actual sample involved was returned for evaluation however, a definitive root cause could not be determined at this time.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: LAP 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: 13726048
• Report Number: 1423395-2022-00008
• Device Sequence Number: 12182132
• Product Code: FDE
• UDI-Device Identifier: 10193489313031
• UDI-Public: 10193489313031
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 03/10/2022

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: DYNJ65158A
• Device Catalogue Number: DYNJ65158A
• Device Lot Number: 21HDA538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/10/2022
• 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: Unknown