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 Host-Tissue Reaction (1297); Swelling (2091)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

Device details unavailable at the time of this report.This report is submitted on september 20, 2018, (b)(4).

Event Description

Per the clinic, the patient experienced skin overgrowth and swelling at the abutment site and the patient was administered oral antibiotics on (b)(6) 2018.Abutment revision is planned; however it is unknown if this has occurred as of the date of this report.

Manufacturer Narrative

It is now reported that the patient underwent revision surgery (date not reported) under general anesthetic.This report is filed on october 3, 2018.

• 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: tamara martin ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7892579
• MDR Text Key: 120824031
• Report Number: 6000034-2018-01944
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• 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: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2018
• 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: 12 YR