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

Model Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/27/2020

Event Type  Injury  

Event Description

Per the clinic, the patient experienced a skin flap issue; the magnet was explanted on (b)(6) 2020.

Event Description

It was reported that the device was explanted on (b)(6) 2020.

Manufacturer Narrative

This report is submitted on 10 september 2020.

Manufacturer Narrative

It was reported the patient experienced infection and was treated with antibiotics on four separate occasions.This report is submitted on 7 october 2020.

Event Description

It was reported the patient experienced infection and was treated with antibiotics on four separate occasions.

• Brand Name: BI300 IMPLANT 4 MM
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM,
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 10412096
• MDR Text Key: 203086533
• Report Number: 6000034-2020-02170
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502025294
• UDI-Public: (01)09321502025294(10)130944(17)231007
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020,09/15/2020

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 Expiration Date: 07/10/2023
• Device Model Number: 92129
• Device Catalogue Number: 92129
• Device Lot Number: 130944
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2020
• Distributor Facility Aware Date: 09/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/09/2020; 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR