MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92130

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced an infection (cellulitis) and inflammation at the abutment site (date not reported).Subsequently, the patient was treated with oral and topical antibiotics (specific date and duration not reported).

• Brand Name: BA300 ABUTMENT 6MM
• 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: 15636961
• MDR Text Key: 302055339
• Report Number: 6000034-2022-03320
• 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
• Report Date: 10/20/2022,09/28/2022

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: 92130
• Device Catalogue Number: 92130
• Device Lot Number: COH200160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2022
• Distributor Facility Aware Date: 09/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female