NORCURON MOCROSTIN PLUS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-05-11 for NORCURON MOCROSTIN PLUS * manufactured by Neurotechnology.

Event Text Entries

[17171324] Nerve stimulator under proximal lead noted dime size area of redness and blister/burn-like appearing. Monitored for further skin breakdown. Applied bactrim ointment to area. Pt paralyzed on respirator due to chronic illness. Nerve stimulator used to assess degree of paralization.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 222683
• MDR Report Key: 222683
• Date Received: 1999-05-11
• Date of Report: 1999-05-07
• Date of Event: 1999-04-29
• Date Facility Aware: 1999-04-29
• Report Date: 1999-05-07
• Date Reported to FDA: 1999-05-11
• Date Reported to Mfgr: 1999-05-11
• Date Added to Maude: 1999-05-13
• 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: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NORCURON
• Generic Name: NERVE STIMULATOR
• Product Code: BXN
• Date Received: 1999-05-11
• Model Number: MOCROSTIN PLUS
• Catalog Number: *
• Lot Number: *
• ID Number: CE# 18422
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 215952
• Manufacturer: NEUROTECHNOLOGY
• Manufacturer Address: 9209 SUMMERBELL LANE HOUSTON TX 770741340 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-05-11