• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92127
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative

The patient's date of initial implantation was not made available at the time of this report. This report is submitted (b)(6) 2016, by cochlear ltd. On behalf of cochlear americas. (b)(4).

 
Event Description

It was reported that the patient experienced recurrent infections with swelling at the implant site. The implanted device remains. Additional information has been requested; however, not made available as of the date of this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBIA300 IMPLANT 4MM W ABUTMENT 6MM
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
bianca hanlon
1 university avenue
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6201430
MDR Text Key63171622
Report Number6000034-2016-02650
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 CONSUMER
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92127
Device Catalogue Number92127
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/22/2016 Patient Sequence Number: 1
-
-