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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93336
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Purulent Discharge (1812); Pain (1994); Staphylococcus Aureus (2058); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on may 02, 2017. (b)(4).

 
Event Description

Per the clinic, the patient experienced infection, swelling, pain, redness and purulent exudate at the abutment site. Cultures returned (b)(6) for (b)(6) infection. Subsequently the patient was treated with oral antibiotics (date and duration not reported); however the issue could not be resolved resulting in the decision to remove the abutment on (b)(6) 2017.

 
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Brand NameBA400 ABUTMENT 12MM
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
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109
AS   2109
94286555
MDR Report Key6536032
MDR Text Key74144639
Report Number6000034-2017-00833
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeEZ
PMA/PMN NumberK121317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial
Report Date 04/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93336
Device Catalogue Number93336
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
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: 05/01/2017 Patient Sequence Number: 1
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