MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM

Model Number 92133

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Foreign Body Reaction (1868); Unspecified Infection (1930); Pain (1994); Skin Irritation (2076); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 25, 2018, by cochlear ltd.On behalf of cochlear americas.(b)(4).

Event Description

Per the clinic, it was reported that the patient underwent a skin revision on (b)(6) 2014 during an abutment replacement.Subsequently, in (b)(6) 2014 the patient experienced an infection.In (b)(6) 2015, the abutment was once again replaced.The site was reportedly clean and dry as of (b)(6) 2015.In (b)(6) 2016, the patient was treated with oral and topical antibiotics due to pain and discharge at the abutment site.   on (b)(6) 2017 the patient reportedly underwent revision surgery and subsequently experienced skin overgrowth and irritation at the abutment site.In (b)(6) 2017, the patient experienced an infection and subsequently underwent an abutment change and removal of granulation tissue on (b)(6) 2017.The patient was treated with oral antibiotics.

• Brand Name: BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE
• 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; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7632819
• MDR Text Key: 112137361
• Report Number: 6000034-2018-01285
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 92133
• Device Catalogue Number: 92133
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/24/2018
• 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