AMERICAN EAGLE INSTRUMENTS AEGDP13-14XPX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-02 for AMERICAN EAGLE INSTRUMENTS AEGDP13-14XPX manufactured by American Eagle Instruments.

MAUDE Entry Details

• Report Number: 1000127001-2019-00001
• MDR Report Key: 8753876
• Date Received: 2019-07-02
• Date of Report: 2019-06-26
• Date of Event: 2019-06-11
• Date Mfgr Received: 2019-06-11
• Device Manufacturer Date: 2011-07-24
• Date Added to Maude: 2019-07-02
• 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: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: CONOR VEGGE
• Manufacturer Street: 6575 BUTLER CREEK RD
• Manufacturer City: MISSOULA MT 59808
• Manufacturer Country: US
• Manufacturer Postal: 59808
• Manufacturer Phone: 4065327301
• Manufacturer G1: AMERICAN EAGLE INSTRUMENTS
• Manufacturer Street: 6575 BUTLER CREEK
• Manufacturer City: MISSOULA MT 59808
• Manufacturer Country: US
• Manufacturer Postal Code: 59808
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: AMERICAN EAGLE INSTRUMENTS
• Generic Name: GRACEY DEEP POCKET CURETTE
• Product Code: EMS
• Date Received: 2019-07-02
• Returned To Mfg: 2019-06-20
• Model Number: AEGDP13-14XPX
• Catalog Number: AEGDP13-14XPX
• Lot Number: 1GP
• Device Expiration Date: 2013-01-24
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: AMERICAN EAGLE INSTRUMENTS
• Manufacturer Address: 6575 BUTLER CREEK RD. MISSOULA MT 59808 US 59808

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-07-02