MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

Model Number 92126

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812)

Event Date 05/29/2015

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 17, 2018, (b)(4).

Event Description

Per the clinic, the patient developed cellulitis at the implant site and was treated with antibiotics (type not reported) on (b)(6) 2015. On (b)(6) 2015, the patient experienced skin overgrowth at the implant site. Subsequently, a biopsy punch was performed in order to expose the implant. On (b)(6) 2016, the patient experienced an infection at the implant site, and was treated with oral antibiotics; however, the issue reoccurred, and the patient presented once more to clinic on (b)(6) 2016, with infection. The patient was treated with another course of oral antibiotics.

• Brand Name: BIA300 IMPLANT 3MM W ABUTMENT 6MM
• 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: 7521086
• MDR Text Key: 108482122
• Report Number: 6000034-2018-01138
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K100360
• 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: 04/19/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/16/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device EXPIRATION Date: 06/30/2016
• Device MODEL Number: 92126
• Device Catalogue Number: 92126
• Device LOT Number: 91160
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/19/2018
• 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 TREATMENT DATA

Date Received: 05/16/2018 Patient Sequence Number: 1