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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Discomfort (2330)

Event Date 03/24/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 12, 2020.

Event Description

Per the clinic, the patient experienced tenderness and discomfort at implant site due to strong magnet retention.It was reported that the patient was seen for revision on (b)(6) 2020 (type of revision not reported).Additional information has been requested but has not been made available as of the date of this report.

• 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: 10045805
• MDR Text Key: 190606449
• Report Number: 6000034-2020-01217
• 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: Other
• Type of Report: Initial
• Report Date: 05/12/2020,04/15/2020

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2020
• Distributor Facility Aware Date: 04/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention