CANNULAIDE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-29 for CANNULAIDE * manufactured by Beevers, Mfg.

Event Text Entries

[910149] Nasal cpap used after extubation. Through hospitalization, pt intubated and extubated to nasal cpap twice. After several days of being on the nasal cpap, it was noted that columella eroded. Two products being used at the same time: cannulaide, beevers mfg and inca nasal prongs. Unable to confirm how one or both contributed more or less to the outcome. Several days of therapy between intubation in 2008.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5008153
• MDR Report Key: 1144408
• Date Received: 2008-08-29
• Date of Report: 2008-08-29
• Date of Event: 2008-03-11
• Date Added to Maude: 2008-09-08
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CANNULAIDE
• Generic Name: CANNULAIDE
• Product Code: NHJ
• Date Received: 2008-08-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 1164437
• Manufacturer: BEEVERS, MFG
• Manufacturer Address: * MCMINNVILLE OR * US

Device Sequence Number: 2

• Brand Name: INCA
• Generic Name: NASAL PRONGS
• Product Code: NHJ
• Date Received: 2008-08-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 2
• Device Event Key: 1164438
• Manufacturer: ADVANTAGE MEDICAL INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2008-08-29