• 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 3MM 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 3MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 08/22/2018
Event Type  Injury  
Manufacturer Narrative

This report is submitted on august 22, 2018, (b)(4).

 
Event Description

Per the clinic, the patient sustained a head trauma and subsequently developed an infection and eventually a hematoma at the abutment site. Revision surgery has been planned to place a healing cap over the site and treat the infection, however, this has not yet occurred as of the date of this report.

 
Manufacturer Narrative

It was reported that the patient was administered a topical steroid and a dressing and a healing cap was placed on (b)(6) 2018.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBI300 IMPLANT 3MM
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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7803720
MDR Text Key117828489
Report Number6000034-2018-01729
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 USER FACILITY
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Type of Report Initial,Followup
Report Date 08/23/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92128
Device Catalogue Number92128
Device LOT NumberCOH888447
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
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: 08/21/2018 Patient Sequence Number: 1
-
-