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

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient had history of chronic skin overgrowth, which was treated with steroid cream.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

This report is submitted on 29 january 2021.

Event Description

It was reported that the patient underwent skin revision surgery on 18 december 2020 to excise skin and tissue at abutment site, the procedure was done under general anaesthesia.

Manufacturer Narrative

This report is submitted on 18 march 2021.

Event Description

Per the clinic, it was reported that the patient underwent revision surgery, in order to convert the patient to a transcutaneous osia baha implant system.During the procedure, the abutment was removed and an implant was placed on the internal fixture.

• Brand Name: ASKU
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 11085055
• MDR Text Key: 224396210
• Report Number: 6000034-2020-03623
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021,02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2021
• Distributor Facility Aware Date: 02/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/28/2021; 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention