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

Model Number ASKU

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient is scheduled to have their baha implant removed due the the device rejecting (date not reported).

Manufacturer Narrative

It was reported the patient was treated with oral and topical antibiotics.This report is submitted on 23 february 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: 9650390
• MDR Text Key: 177159245
• Report Number: 6000034-2020-00272
• 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: 01/31/2020,01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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: 01/31/2020
• Distributor Facility Aware Date: 01/07/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/31/2020
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention