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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930)

Event Date 10/10/2012

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 13, 2018, by cochlear ltd.On behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, the patient developed an infection and was administered topical steroids as treatment in 2012 (exact date not reported).Subsequently, the patient underwent revision surgery to excise overgrown tissue at the abutment site on (b)(6) 2012.It was also reported that the abutment was removed in 2014, subsequent to the patient experiencing an infection once again.

Manufacturer Narrative

The patient was also administered oral antibiotics in 2012 (exact date not reported) which was not included in the initial report.This report is filed on november 21, 2018.

• Brand Name: NI
• 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: tamara martin ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7684450
• MDR Text Key: 113864352
• Report Number: 6000034-2018-01482
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2018
• 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: 40 YR