BIA400 IMPLANT 4MM W ABUTMENT 14MM 93338

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 2020-03-16 for BIA400 IMPLANT 4MM W ABUTMENT 14MM 93338 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[183885286] This report is submitted on 17 march 2020.
Patient Sequence No: 1, Text Type: N, H10

[183885287] Per the clinic, the patient experienced infection at abutment site and subsequently was treated with oral and topical antibiotics. The patient's abutment was replaced.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000034-2020-00694
• MDR Report Key: 9838150
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-16
• Date of Report: 2020-02-19
• Date Mfgr Received: 2020-02-19
• Date Added to Maude: 2020-03-16
• 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. KRISTEL KOHNE
• Manufacturer Street: 1 UNIVERSITY AVENUE
• Manufacturer City: MACQUARIE UNIVERSITY, NSW 2109
• Manufacturer Country: AS
• Manufacturer Postal: 2109
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 14MM
• Generic Name: COCHLEAR BAHA CONNECT SYSTEM
• Product Code: MAH
• Date Received: 2020-03-16
• Model Number: 93338
• Catalog Number: 93338
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• 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	2020-03-16