MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90434

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Irritation (1941); Skin Irritation (2076)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 14, 2019.

Event Description

Per the surgeon, the patient experienced skin irritation around the abutment site.There was a soft tissue revision around the abutment site on (b)(6) 2019 and oral and topical antibiotics were administered.The implant remains in-situ.

• Brand Name: FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
• 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: 9324864
• MDR Text Key: 166497017
• Report Number: 6000034-2019-02388
• 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: Physician
• Type of Report: Initial
• Report Date: 11/14/2019,10/25/2019

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 Model Number: 90434
• Device Catalogue Number: 90434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/14/2019
• Date Report to Manufacturer: 10/25/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR