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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92346
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fluid Discharge (2686); Skin Infection (4544); Implant Pain (4561)
Event Date 06/28/2018
Event Type  Injury  
Manufacturer Narrative

This report is submitted on september 21, 2020.

 
Event Description

Per the clinic, the patient developed a superficial scalp infection and experienced pain and drainage, at the implant site. The skin was debrided and the patient was treated with a topical antibiotic/steroid medication on (b)(6) 2018. It was reported the patient was also treated with a topical ointment and an oral antibiotic daily for a duration of 1 week.

 
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Brand NameBIA300 IMPLANT 4MM W ABUTMENT 9MM
Type of DeviceCOCHLEAR 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
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10558204
MDR Text Key207692149
Report Number6000034-2020-02506
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/31/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92346
Device Catalogue Number92346
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
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: 09/20/2020 Patient Sequence Number: 1
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