MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93332

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 10, 2019.

Event Description

Per the clinic, the patient experienced healing issues at the implant site, resulting in purulent discharge from the site.Subsequently, the patient applied a topical antibiotic to the site and the symptoms subsided (date not reported).

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 12MM
• 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 pries ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8978449
• MDR Text Key: 157040016
• Report Number: 6000034-2019-01743
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• 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