MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93550

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

Patient Problems Unspecified Infection (1930); Necrosis Of Flap Tissue (1972)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced skin necrosis over the magnet site; subsequently the magnet was explanted, and the patient and was treated with oral antibiotics (duration and specific date not reported).

Manufacturer Narrative

It is now reported that the patient experienced an infection.This report is submitted on november 13, 2020.

Event Description

It is now reported that the patient experienced an infection.

• Brand Name: BIM400 IMPLANT MAGNET
• 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: 10411934
• MDR Text Key: 203088516
• Report Number: 6000034-2020-02145
• 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: 11/13/2020,10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93550
• Device Catalogue Number: 93550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2020
• Distributor Facility Aware Date: 10/09/2020
• Date Report to Manufacturer: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention