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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92126
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)
Event Date 11/27/2019
Event Type  Injury  
Manufacturer Narrative

This report is submitted on february 11, 2020.

 
Event Description

Per the surgeon, the patient experienced an infection at the abutment site which was treated with antibiotics (iv, oral and topical). The abutment was removed under a general anaesthetic. The implant remains in-situ.

 
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Brand NameBIA300 IMPLANT 3MM 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
roberta loveday
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key9691295
MDR Text Key178516549
Report Number6000034-2020-00362
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeAS
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 01/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92126
Device Catalogue Number92126
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 Received01/20/2020
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: 02/11/2020 Patient Sequence Number: 1
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