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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 Biocompatibility (2886)
Patient Problem Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative

Additional information has been requested regarding the device details; however, have not been made available as of the date of this report. Should further information be provided, a supplementary report shall be submitted. This report is submitted on february 27, 2020.

 
Event Description

It was reported that the patient developed skin irritation at the implant site and subsequently applied a topical antibiotic to the site (date and duration not reported).

 
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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 Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9759687
MDR Text Key181776335
Report Number6000034-2020-00489
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Type of Report Initial
Report Date 01/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2020
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 NumberASKU
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2020
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: 02/26/2020 Patient Sequence Number: 1
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