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

Model Number ASKU

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on january 11, 2021.

Event Description

Per the clinic, the patient experienced chronic infection at the abutment site.Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

Per the clinic, it was reported that the patient underwent surgical cleaning of the site of the infection (date not reported).This report is submitted february 16, 2021.

• 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: 11144322
• MDR Text Key: 225995035
• Report Number: 6000034-2021-00131
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2021
• 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?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention