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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced skin overgrowth and an infection.However, the issue could not be resolved.The device was explanted on (b)(6) 2021.Reimplantation is planned but has not taken place as of the date of this report.

Event Description

Per the clinic, it is now reported that there was no infection.

• Brand Name: NI
• Type of Device: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 3 3; SW 435 33
• MDR Report Key: 12340522
• MDR Text Key: 267211001
• Report Number: 6000034-2021-02470
• 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: 09/13/2021,08/23/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Distributor Facility Aware Date: 08/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention