ASKU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-15 for ASKU manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[183471894] This report is submitted on 16 march 2020.
Patient Sequence No: 1, Text Type: N, H10

[183471895] Per the clinic, it was reported that due to pain, the internal magnet was removed in order to convert the patient to a percutaneous baha implant system. An abutment was placed on the implant fixture, which remains insitu.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000034-2020-00737
• MDR Report Key: 9833231
• Report Source: USER FACILITY
• Date Received: 2020-03-15
• Date of Report: 2020-02-18
• Date of Event: 2020-02-18
• Date Mfgr Received: 2020-02-18
• Date Added to Maude: 2020-03-15
• 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: ASKU
• Generic Name: COCHLEAR BAHA CONNECT SYSTEM
• Product Code: LXB
• Date Received: 2020-03-15
• Model Number: ASKU
• Catalog Number: ASKU
• 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	2020-03-15