MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXI300 IMPLANT 3MM; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 93100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 1, 2017, by cochlear ltd.On behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, it was reported that the patient experienced an infection and skin over-growth at the implant site and was subsequently treated with an antibiotic ointment.

• Brand Name: COCHLEAR¿ VISTAFIX® VXI300 IMPLANT 3MM
• Type of Device: COCHLEAR BAHA VISTAFIX 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: 7073851
• MDR Text Key: 93415842
• Report Number: 6000034-2017-02203
• Device Sequence Number: 1
• Product Code: FZE
• UDI-Device Identifier: 09321502021715
• UDI-Public: (01)09321502021715(10)167321(17)191130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945154
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: 93100
• Device Catalogue Number: 93100
• Device Lot Number: 167321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• 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