LICOX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for LICOX manufactured by Integra Lifesciences (ireland) Limited.

Event Text Entries

[173501871] After completing pt bath, 10 mg propofol bolus given prior to repositioning. 2 rn began repositioning pt onto right side when pt began violently coughing and thrashing upper body and head back and forth. Additional 50 mcg fentanyl bolus given. Rn observed blood tinged csf pouring onto bed as pt continued coughing. Both rn immediately positioned pt onto back and raised hob to 45 degrees. While assessing pt, fiberoptic piece from licox/camino bolt dislodged and fell onto pt's bed. Blood tinged csf expelled out of bolt device. One rn held gloved hand over site to stop csf while another rn ran to grab cap to stop csf pouring out. Writer rn stayed at bedside holding pt in place to immobilize. Sterile blue cap placed over opening of bolt. Paged neurosurgery resident on call immediately during event to assess pt and licox/camino. Neurosurgery physician returned page and promptly at bedside. Per neurosurgery physician, keep sterile blue cap screwed onto bolt piece until further evaluation in am as well as leave evd unclamped when repositioning pt. Continuous leaking around bolt site, neurosurgery resident at bedside to assess, bolt removed after consulting neurosurgery team.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9544030
• MDR Report Key: 9544030
• Date Received: 2020-01-03
• Date of Report: 2019-10-09
• Date of Event: 2019-10-06
• Report Date: 2019-10-09
• Date Reported to FDA: 2019-10-09
• Date Reported to Mfgr: 2020-01-03
• Date Added to Maude: 2020-01-03
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LICOX
• Generic Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Product Code: GWM
• Date Received: 2020-01-03
• Lot Number: 0213478
• Device Availability: N
• Device Age: 1 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Manufacturer Address: 1100 CAMPUS RD PRINCETON NJ 08540 US 08540

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-03