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 Problems Skin Irritation (2076); Swelling (2091)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced recurrent skin irritation and swelling at the abutment site, and subsequently was treated with oral and topical antibiotics.

Event Description

It was reported that the patient underwent a skin revision surgery which was performed under general anesthesia.

• 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: 10411964
• MDR Text Key: 203088568
• Report Number: 6000034-2020-02206
• 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: 10/07/2020,09/15/2020

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: 10/07/2020
• Distributor Facility Aware Date: 09/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention