PROSTHESIS - FLEX HA 0550

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-08-14 for PROSTHESIS - FLEX HA 0550 manufactured by Medtronic Xomed Inc..

MAUDE Entry Details

• Report Number: 1045254-2019-00383
• MDR Report Key: 8893069
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2019-08-14
• Date of Report: 2019-08-14
• Date of Event: 2019-07-16
• Date Mfgr Received: 2019-07-22
• Device Manufacturer Date: 2017-06-27
• Date Added to Maude: 2019-08-14
• 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: CHRISTY CAIN
• Manufacturer Street: 6743 SOUTHPOINT DRIVE NORTH
• Manufacturer City: JACKSONVILLE FL 32216
• Manufacturer Country: US
• Manufacturer Postal: 32216
• Manufacturer Phone: 9043328353
• Manufacturer G1: MEDTRONIC XOMED INC.
• Manufacturer Street: 6743 SOUTHPOINT DR N
• Manufacturer City: JACKSONVILLE FL 32216
• Manufacturer Country: US
• Manufacturer Postal Code: 32216
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PROSTHESIS - FLEX HA
• Generic Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Product Code: ETA
• Date Received: 2019-08-14
• Model Number: 0550
• Catalog Number: 0550
• Lot Number: 0213544652
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC XOMED INC.
• Manufacturer Address: 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-14