SURGICAL CO2 LASER CE 0434

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-23 for SURGICAL CO2 LASER CE 0434 manufactured by Lutronic.

Event Text Entries

[16864766] Six days after a laser "vitrification" procedure on a fractured right mandibular molar to "prevent a root canal", i was hospitalized with intractable vomiting, ataxia, vertigo, diplopia, hearing loss and other cranial nerve deficits. I was admitted to the neuro intensive care unit and treated as a stroke patient. Seven weeks later, after discharge from a rehabilitation hospital and bi-weekly physical therapy sessions my condition was markedly improved. Unfortunately, i relapsed and was hospitalized again for the same symptoms and the new onset of electrical shock sensations affecting the right face. I rec'd a diagnosis of multiple sclerosis and was started on high-dose steroids with a three week taper after discharge. A couple of weeks after discharge in (b)(6), while tapering off steroids, i developed spasms in the right face. Facial rehabilitation partially resolved the problem. At my clinic f/u in neurology, there was talk of autoimmune disease and plasmapheresis which was never performed due to improvement in my clinical condition. At the following clinic visit, the diagnosis of adem was suggested and this has remained the working diagnosis.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5036884
• MDR Report Key: 3901876
• Date Received: 2014-06-23
• Date of Report: 2014-06-20
• Date of Event: 2013-07-02
• Date Added to Maude: 2014-07-01
• Event Key: 0
• Report Source Code: Voluntary 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: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SURGICAL CO2 LASER
• Generic Name: LASER
• Product Code: EWG
• Date Received: 2014-06-23
• Model Number: CE 0434
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: LUTRONIC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Deathisabilit	2014-06-23