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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Host-Tissue Reaction (1297); Swelling (2091)
Event Date 07/26/2018
Event Type  Injury  
Manufacturer Narrative

Device details unavailable at the time of this report. This report is submitted on september 20, 2018, (b)(4).

 
Event Description

Per the clinic, the patient experienced skin overgrowth and swelling at the abutment site and the patient was administered oral antibiotics on (b)(6) 2018. Abutment revision is planned; however it is unknown if this has occurred as of the date of this report.

 
Manufacturer Narrative

It is now reported that the patient underwent revision surgery (date not reported) under general anesthetic. This report is filed on october 3, 2018.

 
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Brand NameASKU
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 Key7892579
MDR Text Key120824031
Report Number6000034-2018-01944
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 09/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Device Catalogue NumberASKU
Device LOT NumberN/A
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 Received09/21/2018
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: 09/20/2018 Patient Sequence Number: 1
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