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

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Device and initial implantation details unavailable at the time of this report, this report is submitted on (b)(6) 2016, by (b)(4).

Event Description

Per the clinic, it was reported that the patient experienced infection at abutment site, clinical management is ongoing.

Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2015, and (b)(6) 2016, to debride the skin at the implant site.The patient's infection was treated with oral antibiotics on three occasions.The first, on (b)(6) 2015 (duration not reported), the second on (b)(6) 2016, for a duration of 10 days, and the third on (b)(6) 2016, for a duration of 10 days.The issue reportedly could not be resolved, resulting in the decision to remove the abutment.The implanted device remains insitu.

• Brand Name: UNKNOWN
• 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 Contact: bianca hanlon ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 94286555
• MDR Report Key: 6197454
• MDR Text Key: 63048823
• Report Number: 6000034-2016-02511
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention