• 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 BI300 IMPLANT 4 MM 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 BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92129
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/10/2017
Event Type  Injury  
Manufacturer Narrative

This report is submitted on december 29, 2017. (b)(4).

 
Event Description

Per the clinic, the patient's device was explanted on (b)(6) 2017 due to non-device related medical reasons. There are no plans to re-implant the patient as of the date of this report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBI300 IMPLANT 4 MM
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
kristel kohne
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key7153419
MDR Text Key96002381
Report Number6000034-2017-02380
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92129
Device Catalogue Number92129
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2017
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
Was Device Evaluated By Manufacturer? No
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: 12/28/2017 Patient Sequence Number: 1
-
-