DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV, REFUBISHED N/A UE514010400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-11 for DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV, REFUBISHED N/A UE514010400 manufactured by Dornoch.

MAUDE Entry Details

• Report Number: 0001954182-2020-00016
• MDR Report Key: 9819285
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2020-03-11
• Date of Report: 2020-04-02
• Date of Event: 2020-03-09
• Date Mfgr Received: 2020-04-01
• Date Added to Maude: 2020-03-11
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. CHRISTINA ARNT
• Manufacturer Street: 56 E. BELL DRIVE
• Manufacturer City: WARSAW IN 46582
• Manufacturer Country: US
• Manufacturer Postal: 46582
• Manufacturer Phone: 5745273773
• Manufacturer G1: DORNOCH
• Manufacturer Street: 200 NORTHWEST PARKWAY
• Manufacturer City: RIVERSIDE MO 64150
• Manufacturer Country: US
• Manufacturer Postal Code: 64150
• Single Use: 3
• Previous Use Code: 3
• Removal Correction Number: N/A
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV, REFUBISHED
• Generic Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Product Code: JCX
• Date Received: 2020-03-11
• Model Number: N/A
• Catalog Number: UE514010400
• Lot Number: N/A
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DORNOCH
• Manufacturer Address: 200 NORTHWEST PARKWAY RIVERSIDE MO 64150 US 64150

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-11