MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92128

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 29, 2019.

Event Description

Per the clinic, the patient experienced an infection at the abutment site.It is unknown what treatment was administered for the infection.The implant remains in-situ.

Event Description

Per the clinic, the patient underwent a procedure to remove infected tissue over the abutment site (date not reported).The patient will continue to be clinically managed by their healthcare provider.

• Brand Name: BI300 IMPLANT 3 MM
• 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: 9390635
• MDR Text Key: 168434728
• Report Number: 6000034-2019-02810
• 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: 12/24/2019,12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/24/2019
• Distributor Facility Aware Date: 12/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR