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

Model Number	DYNJ49951J
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility the 'raytec gauze were coming apart and leaving fragments in the patient which had to be manually retrieved'.Per the facility the fragments were noticed in the beginning and the middle of the procedure.The fragments were manually retrieved and removed from the patient and the product was removed from the field and replaced with another.According to the facility the procedure was completed after extended surgical time, and there was no reports of serious injury to the patient.The sample was requested to be returned for evaluation but was not available.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.
Event or Problem Description
According to the facility the 'raytec gauze were coming apart and leaving fragments in the patient which had to be manually retrieved'.

• Brand Name: Medline Industries, Inc.
• Common Device Name: MP NEURO 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: 14187143
• Report Number: 1423395-2022-00014
• Device Sequence Number: 4261579
• Product Code: OJG
• UDI-Device Identifier: 10193489857627
• UDI-Public: 10193489857627
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 04/22/2022

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: DYNJ49951J
• Device Catalogue Number: DYNJ49951J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 04/22/2022
• 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: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 85 KG