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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

Device and initial implantation details unavailable at the time of this report, this report is submitted on (b)(6) 2016, by (b)(4).

 
Event Description

Per the clinic, it was reported that the patient experienced infection at abutment site, clinical management is ongoing.

 
Manufacturer Narrative

Per the clinic, the patient underwent revision surgery on (b)(6) 2015, and (b)(6) 2016, to debride the skin at the implant site. The patient's infection was treated with oral antibiotics on three occasions. The first, on (b)(6) 2015 (duration not reported), the second on (b)(6) 2016, for a duration of 10 days, and the third on (b)(6) 2016, for a duration of 10 days. The issue reportedly could not be resolved, resulting in the decision to remove the abutment. The implanted device remains insitu.

 
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Brand NameUNKNOWN
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
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6197454
MDR Text Key63048823
Report Number6000034-2016-02511
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
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 Received01/03/2017
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

Patient TREATMENT DATA
Date Received: 12/21/2016 Patient Sequence Number: 1
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