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

Model Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 18, 2020.

Event Description

Per the clinic, the abutment was removed due to an infection. Treatment for the infection is unknown.

• 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: 11033365
• MDR Text Key: 222270775
• Report Number: 6000034-2020-03477
• 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
• Report Date: 01/28/2021,01/05/2021

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/17/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: ASKU
• Was Device Available For Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2021
• Distributor Facility Aware Date: 01/05/2021
• Event Location: No Information
• Date Report TO Manufacturer: 10/28/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 12/17/2020 Patient Sequence Number: 1