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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/07/2020
Event Type  Injury  
Event Description

Per the clinic, the patient experienced an infection at the abutment site, and subsequently was treated with antibiotics (specific type, date, and duration not reported); however the issue could not be resolved. Subsequently, the device was explanted on (b)(6) 2020. The patient has not been reimplanted with a new device as of this report.

 
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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
MDR Report Key10738116
MDR Text Key213160810
Report Number6000034-2020-03006
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 Distributor
Reporter Occupation
Type of Report Initial
Report Date 10/27/2020,10/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/26/2020
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/27/2020
Distributor Facility Aware Date10/05/2020
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/26/2020 Patient Sequence Number: 1
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