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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6) 2017. (b)(4).

Event Description

Per the clinic, the patient experienced a hematoma at implant site post implantation surgery; subsequently the patient remained in hospital and underwent a procedure to drain the site. The implanted device remains.

• Brand Name: NI
• 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
• Manufacturer Contact: kristel kohne ; 1 university avenue; macquarie university, nsw 2109, ; AS 2109,
• MDR Report Key: 7111305
• MDR Text Key: 94619958
• Report Number: 6000034-2017-02219
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (Y/N): N
• Reporter Country Code: CH
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL
• Reporter Occupation: HEALTH PROFESSIONAL
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/12/2017
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 12/12/2017 Patient Sequence Number: 1