MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 8MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93330

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Pain (1994)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 02, 2018, (b)(4).

Event Description

Per the audiologist, it was reported that the patient experienced discharging pus at the wound site on (b)(6) 2018.On (b)(6) 2018 the patient underwent skin revision due to skin overgrowth at the abutment site.In (b)(6) 2018 the patient experienced pain, itchiness and skin overgrowth.It was reported that the patient was administered a topical antibiotic on (b)(6) 2018 for infection.On (b)(6)2018 the abutment was removed.There are plans to place a magnet on the internal fixture but has yet to occur as of the date of this report.

Manufacturer Narrative

Per the clinic, it was reported that the patient underwent revision to have a magnet placed on the internal fixture on (b)(6) 2018, converting the patient to a subcutaneous baha implant system.This report is submitted on january 14, 2019.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 8MM
• 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: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7925019
• MDR Text Key: 122296361
• Report Number: 6000034-2018-01979
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502022705
• UDI-Public: (01)09321502022705(10)COH1135364(17)221102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/02/2022
• Device Model Number: 93330
• Device Catalogue Number: 93330
• Device Lot Number: COH1135364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 53 YR