MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM

Model Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2023

Event Type  Injury  

Event Description

Per the clinic, the device was explanted on (b)(6) 2023.It is unknown if there are plans to reimplant the patient as of the date of this report.Additional information has been requested but it has not been made available as of the date of this report.

Event Description

Correction: the initial mdr submitted on august 31, 2023 was filed inadvertently.No device malfunction, explantation or serious injury has occurred.The device was not a cochlear device.This report is submitted on september 21, 2023.

• Brand Name: ASKU
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 17658890
• MDR Text Key: 322360243
• Report Number: 6000034-2023-02843
• Device Sequence Number: 1
• Product Code: MAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2023,09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2023
• Distributor Facility Aware Date: 09/12/2023
• Date Report to Manufacturer: 09/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male