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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930)
Event Date 10/10/2012
Event Type  Injury  
Manufacturer Narrative

This report is submitted on july 13, 2018, by cochlear ltd. On behalf of cochlear americas. (b)(4).

 
Event Description

Per the clinic, the patient developed an infection and was administered topical steroids as treatment in 2012 (exact date not reported). Subsequently, the patient underwent revision surgery to excise overgrown tissue at the abutment site on (b)(6) 2012. It was also reported that the abutment was removed in 2014, subsequent to the patient experiencing an infection once again.

 
Manufacturer Narrative

The patient was also administered oral antibiotics in 2012 (exact date not reported) which was not included in the initial report. This report is filed on november 21, 2018.

 
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Brand NameNI
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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
tamara martin
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key7684450
MDR Text Key113864352
Report Number6000034-2018-01482
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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 Received06/21/2018
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: 07/12/2018 Patient Sequence Number: 1
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