MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION CODMAN; NEUROLOGICAL TRAY

Model Number	826614
Health Effect - Clinical Code	Pneumocephalus (4587)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Cap breakage from evd (external ventricular drainage) system resulting in pneumocephalus.

• Brand Name: CODMAN
• Common Device Name: NEUROLOGICAL TRAY
• Manufacturer (Section D): INTEGRA LIFESCIENCES PRODUCTION CORPORATION; 11 cabot blvd; mansfield MA 02048
• MDR Report Key: 19557126
• Report Number: 19557126
• Device Sequence Number: 4734767
• Product Code: OJG
• UDI-Device Identifier: 10381780520375
• UDI-Public: (01)10381780520375
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/29/2024
• Report Date (Section F): 05/29/2024

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
• Device Model Number: 826614
• Device Catalogue Number: 82-6614
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2024
• 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; Hospitalization
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/29/2024