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

Model Number ASKU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Bacterial Infection (1735); Staphylococcus Aureus (2058)

Event Date 07/23/2015

Event Type  Death  

Manufacturer Narrative

Additional information was requested regarding the product details; however, were not made available as of the date of this report.This report is submitted on march 5, 2018, (b)(4).

Event Description

Per the clinic, it was reported that the patient experienced recurrent skin infections and overgrowth at the implant site.The first occurrence, on (b)(6) 2015, was treated with oral antibiotics.The second occurrence on (b)(6) 2016, the patient presented with a small abscess.Cultures returned staphylococcus aureus and streptococcal, therefore the patient was treated with oral and topical antibiotics.On (b)(6) 2017, the patient presented to the ed with an infection and drainage at the implant site.Subsequently, the patient was treated with oral and topical antibiotics.On (b)(6) 2017, the patient was seen for follow up and treated with an additional course of oral antibiotics.On (b)(6) 2018, the patient's abutment was removed.Cultures returned multiple organisms, and the patient was treated once more with oral antibiotics.The patient has discontinued use of the device; however, the fixture remains insitu.

• Brand Name: ASKU
• 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: 7312365
• MDR Text Key: 101460996
• Report Number: 6000034-2018-00504
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2018
• 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: 8 YR