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

Model Number ASKU

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Skin Infection (4544); Insufficient Information (4580)

Event Date 10/24/2023

Event Type  Injury  

Event Description

Per the clinic, the patient was placed under general anaesthesia on (b)(6) 2023 in order to replace the abutment.Additional information has been requested but has not been made available as of the date of this report.

Event Description

Per the clinic, the patient experienced an infection at the abutment site and subsequently was treated with topical antibiotics on (b)(6) 2023 (specific duration not reported) and injectable steroid in (b)(6) 2023 (specific date and duration not reported).The patient also underwent skin revision surgery to remove excess skin on (b)(6) 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: 18288973
• MDR Text Key: 329993181
• Report Number: 6000034-2023-03945
• Device Sequence Number: 1
• Product Code: LXB
• 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: 01/03/2024,12/11/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2024
• Distributor Facility Aware Date: 12/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/02/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female