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

Model Number BIM400

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is filed october 5, 2016.Implanted device remains.

Event Description

Per the clinic, the patient developed swelling at the implant site and was treated with antibiotics (date not reported).

• Brand Name: COCHLEAR BAHA ATTRACT SYSTEM
• Type of Device: LXB
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 435 33, ; SW
• Manufacturer (Section G): COCHLEAR AMERICAS; 13059 east peakview avenue; centennial, co 80111, us
• Manufacturer Contact: pavana nayak ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 5998893
• MDR Text Key: 56441272
• Report Number: 6000034-2016-01944
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BIM400
• Device Catalogue Number: 93550
• Device Lot Number: 108997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/16/2016
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: No
• 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