COHERENT 4000 RM 3874 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-16 for COHERENT 4000 RM 3874 * manufactured by *.

Event Text Entries

[36026] Co2 laser caused charring to vocal cord. Pre-op set-up instructional improved. Dr reports that pt will heal without defects.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 56909
• MDR Report Key: 56909
• Date Received: 1996-12-16
• Date of Report: 1996-05-17
• Date of Event: 1996-05-17
• Date Added to Maude: 1996-12-20
• 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
• 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: COHERENT 4000
• Generic Name: CO2 LASER
• Product Code: EWG
• Date Received: 1996-12-16
• Model Number: RM 3874
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 57422
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	1996-12-16