MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 92128

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Irritation (2076)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on on february 08, 2018.(b)(4).

Event Description

Per the audiologist, the patient experienced thinning of tissue, irritation and redness at magnet site resulting in non-use of the device for periods of time.On (b)(6) 2018 the magnet was replaced.The patient is being clinically managed by their healthcare provider.

Manufacturer Narrative

It was reported that the patient was treated with a topical antibiotic (date and duration not reported).(b)(4).

• Brand Name: BI300 IMPLANT 3MM
• 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 (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7250558
• MDR Text Key: 99296263
• Report Number: 6000034-2018-00252
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019538
• UDI-Public: (01)09321502019538(10)170823(17)200229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: 92128
• Device Catalogue Number: 92128
• Device Lot Number: 170823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2018
• 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
• Patient Age: 21 YR