EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM 46700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-23 for EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM 46700 manufactured by Medtronic Mexico.

MAUDE Entry Details

• Report Number: 9612164-2020-01307
• MDR Report Key: 9869292
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2020-03-23
• Date of Report: 2020-03-31
• Date of Event: 2020-03-13
• Date Mfgr Received: 2020-03-25
• Device Manufacturer Date: 2019-05-23
• Date Added to Maude: 2020-03-23
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: KATCHA TAYLOR
• Manufacturer Street: 9775 TOLEDO WAY
• Manufacturer City: IRVINE CA 92618
• Manufacturer Country: US
• Manufacturer Postal: 92618
• Manufacturer Phone: 9496801345
• Manufacturer G1: MEDTRONIC MEXICO
• Manufacturer Street: AV. PASEO DEL CUCAPAH #10510
• Manufacturer City: TIJUANA,BC 22570
• Manufacturer Country: MX
• Manufacturer Postal Code: 22570
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: EXACTA EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Generic Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Product Code: GWM
• Date Received: 2020-03-23
• Model Number: 46700
• Catalog Number: 46700
• Lot Number: 217755633
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC MEXICO
• Manufacturer Address: AV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2020-03-23