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.

• 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
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor

Reporter Occupation

• 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

• Date FDA Received: 08/17/2020
• 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
• Device LOT Number: 130944
• 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: 10/07/2020
• Distributor Facility Aware Date: 09/15/2020
• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 08/17/2020 Patient Sequence Number: 1