MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92129

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 20, 2017.(b)(4).

Event Description

Per the clinic, the patient developed redness and granulation of the tissue at the abutment site.Subsequently, the patient was treated with oral antibiotics and the site was treated an antibacterial cream and silver nitrate.

• Brand Name: BI300 IMPLANT 4 MM
• 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 (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke 43533 ; SW 43533
• Manufacturer Contact: bianca pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 6964064
• MDR Text Key: 89793258
• Report Number: 6000034-2017-01873
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502019545
• UDI-Public: (01)09321502019545
• Combination Product (y/n): N
• Reporter Country Code: IZ
• PMA/PMN Number: K100360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2017

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: 92129
• Device Catalogue Number: 92129
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention