MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced pain and granulation at abutment site (date not reported) which was treated with a steroid injection on (b)(6) 2021, and oral steroids (duration not reported).However, the issue did not resolve.The patient was then prescribed oral antibiotics for a duration of 10 days on (b)(6) 2021, and topical antibiotics on (b)(6) 2021 (duration not reported).On (b)(6) 2021, the patient experienced infection and discharge which was treated with oral antibiotics (duration not reported), however, the symptoms did not resolve.Subsequently, the patient was prescribed with another round of oral antibiotics on (b)(6) 2021, for a duration of 10 days.On (b)(6) 2021, the patient experienced swelling, redness and crusting overgrowing the abutment site which was resolved on (b)(6) 2021.

Event Description

Per the clinic, the device was explanted on (b)(6) 2022.

• Brand Name: BI300 IMPLANT 4 MM
• 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: 13494832
• MDR Text Key: 285316646
• Report Number: 6000034-2022-00379
• 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: 05/06/2022,04/17/2022

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: 92129
• Device Catalogue Number: 92129
• 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: 05/06/2022
• Distributor Facility Aware Date: 04/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male