BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-27 for BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER 109381603 manufactured by Avanos Medical Inc..

MAUDE Entry Details

• Report Number: 3011270181-2019-00041
• MDR Report Key: 9132101
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2019-09-27
• Date of Report: 2019-11-27
• Date of Event: 2019-08-30
• Date Mfgr Received: 2019-11-04
• Date Added to Maude: 2019-09-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Manufacturer Contact: MS. LISA CLARK
• Manufacturer Street: 5405 WINDWARD PARKWAY
• Manufacturer City: ALPHARETTA GA 30004
• Manufacturer Country: US
• Manufacturer Postal: 30004
• Manufacturer Phone: 4704485444
• Manufacturer G1: TRINITY MEDICAL DEVICES INC.
• Manufacturer Street: 1 PLUCKEMIN WAY
• Manufacturer City: BEDMINSTER NJ 07921
• Manufacturer Country: US
• Manufacturer Postal Code: 07921
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER
• Generic Name: VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
• Product Code: BYD
• Date Received: 2019-09-27
• Model Number: 150
• Catalog Number: 109381603
• Lot Number: 20-1904-158
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AVANOS MEDICAL INC.
• Manufacturer Address: 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-09-27