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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4 MM W. ABUTMENT 6 MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92127
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on (b)(6) 2016 by (b)(4). Implanted device remains.

 
Event Description

Per the clinic, the patient developed an mrsa infection at the abutment site and was treated with topical antibiotics (date not reported). The implanted device remains.

 
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Brand NameBIA300 IMPLANT 4 MM W. ABUTMENT 6 MM
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 435 33,
SW
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east peakview avenue
centennial, co 80111, us
Manufacturer Contact
pavana nayak
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key6052946
MDR Text Key58243017
Report Number6000034-2016-02171
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 HEALTH PROFESSIONAL
Type of Report Initial
Report Date 10/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/24/2016
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 Number95362
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/20/2016
Event Location No Information
Date Manufacturer Received10/20/2016
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 Initial

Patient TREATMENT DATA
Date Received: 10/24/2016 Patient Sequence Number: 1
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