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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM

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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 Host-Tissue Reaction (1297); Unspecified Infection (1930); Pain (1994)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on july 13, 2018, (b)(4).

 
Event Description

It was reported that the patient experienced skin overgrowth, recurrent infections and persistent pain at the abutment site for over 12 months. Subsequently, new implant and a magnet were placed at a different site on (b)(6) 2017.

 
Manufacturer Narrative

Per the surgeon, it is now reported that the infection was treated with antibiotics and steroids (date and duration not reported) and the site was debrided; however the issue could not resolved.

 
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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 Key7684478
MDR Text Key113864603
Report Number6000034-2018-01523
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,Followup
Report Date 07/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/20/2021
Device MODEL Number92128
Device Catalogue Number92128
Device LOT NumberCOH888447
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2018
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: 07/12/2018 Patient Sequence Number: 1
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