COCHLEAR? VISTAFIX? VXA300 ABUTMENT 6MM 92996

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-09-09 for COCHLEAR? VISTAFIX? VXA300 ABUTMENT 6MM 92996 manufactured by Cochlear Bone Anchored Solutions Ab.

MAUDE Entry Details

• Report Number: 6000034-2019-01882
• MDR Report Key: 8978373
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-09-09
• Date of Report: 2019-08-20
• Date Facility Aware: 2019-08-20
• Report Date: 2019-09-10
• Date Reported to FDA: 2019-09-10
• Date Mfgr Received: 2019-08-20
• Date Added to Maude: 2019-09-09
• 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: MR. YI FENG
• Manufacturer Street: 1 UNIVERSITY AVENUE
• Manufacturer City: MACQUARIE UNIVERSITY, NSW 2109
• Manufacturer Country: AS
• Manufacturer Postal: 2109
• Manufacturer G1: COCHLEAR BONE ANCHORED SOLUTIONS AB
• Manufacturer Street: KONSTRUKTIONSV PO BOX 82
• Manufacturer City: 43533
• Manufacturer Country: SW
• Manufacturer Postal Code: 43533
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COCHLEAR? VISTAFIX? VXA300 ABUTMENT 6MM
• Generic Name: COCHLEAR BAHA VISTAFIX SYSTEM
• Product Code: FZE
• Date Received: 2019-09-09
• Model Number: 92996
• Catalog Number: 92996
• Lot Number: NI
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COCHLEAR BONE ANCHORED SOLUTIONS AB
• Manufacturer Address: KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-09