LTA KIT, LIDOCAIN HCL TOPICAL SO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for LTA KIT, LIDOCAIN HCL TOPICAL SO manufactured by Interantional Medical Systems.

Event Text Entries

[127395910] Pt scheduled for parotid resection. Oropharyngeal anesthesia, tip of catheter was missing. Pt underwent bronchoscopy through endotracheal tube, catheter tip noted in right main stem bronchus and removed with biopsy forceps. The distal tip of lta kit (laryng o spray) used prior to intubation but after pt was asleep to numb the trachea for neck surgeries.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5081259
• MDR Report Key: 8071019
• Date Received: 2018-11-13
• Date of Report: 2018-11-06
• Date of Event: 2018-10-30
• Date Added to Maude: 2018-11-14
• 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: 3
• 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: 0

Device Sequence Number: 0

• Brand Name: LTA KIT, LIDOCAIN HCL TOPICAL SO
• Generic Name: APPLICATION LARYNGOTRACHEAL TOPICAL ANESTHESIA
• Product Code: CCT
• Date Received: 2018-11-13
• Lot Number: DJ089CB
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: INTERANTIONAL MEDICAL SYSTEMS
• Manufacturer Address: SOUTH EL MONTE CA US

Device Sequence Number: 1

• Brand Name: LTA KIT, LIDOCAIN HCL TOPICAL SO
• Generic Name: APPLICATION LARYNGOTRACHEAL TOPICAL ANESTHESIA
• Product Code: CCT
• Date Received: 2018-11-13
• Lot Number: DJ089CB
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTERANTIONAL MEDICATION SYSTEMS
• Manufacturer Address: SOUTH EL MONTE CA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2018-11-13