MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93336

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 02, 2017.(b)(4).

Event Description

Per the clinic, the patient experienced infection, swelling, pain, redness and purulent exudate at the abutment site.Cultures returned (b)(6) for (b)(6) infection.Subsequently the patient was treated with oral antibiotics (date and duration not reported); however the issue could not be resolved resulting in the decision to remove the abutment on (b)(6) 2017.

• Brand Name: BA400 ABUTMENT 12MM
• 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
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109 ; 94286555
• MDR Report Key: 6536032
• MDR Text Key: 74144639
• Report Number: 6000034-2017-00833
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93336
• Device Catalogue Number: 93336
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention