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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90434
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative

This report is submitted (b)(6) 2016, by (b)(4).

 
Event Description

It was reported that the patient experienced chronic infections and swelling at the implant site. Additional information has been requested; however, not yet received.

 
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Brand NameFLANGE FIXTURE ST 4MM W. BAHA ABUTMENT
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
bianca hanlon
1 university avenue
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6192096
MDR Text Key62905152
Report Number6000034-2016-02470
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 11/30/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number90434
Device Catalogue Number90434
Device LOT Number016CMC
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
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

Patient TREATMENT DATA
Date Received: 12/20/2016 Patient Sequence Number: 1
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