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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 Loss of Osseointegration (2408)
Patient Problem Hearing Impairment (1881)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the recipient experienced a loss of osseointegration(date not reported). As per the clinic, there was no medicine prescribed for the skin where the baha system fell out as this was already well healed. The recipient is now wearing his baha 5 power on a softband.

 
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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
43533
SW 43533
Manufacturer Contact
yi feng
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9243417
MDR Text Key163893434
Report Number6000034-2019-02129
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 10/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/27/2019
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?
Was the Report Sent to FDA?
Distributor Facility Aware Date10/04/2019
Event Location Home
Date Manufacturer Received10/04/2019
Was Device Evaluated By Manufacturer? No Answer Provided
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: 10/27/2019 Patient Sequence Number: 1
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