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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 Problem Hearing Impairment (1881)
Event Date 03/05/2020
Event Type  Injury  
Event Description

Per the clinic, due to poor sound quality the patient underwent revision surgery on (b)(6) 2020, in order to convert the patient to a percutaneous baha implant system. During the procedure, the internal magnet was removed and an abutment was placed on the internal fixture.

 
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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 Key9914491
MDR Text Key186732206
Report Number6000034-2020-00952
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 04/02/2020,03/12/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/01/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Device Catalogue NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/02/2020
Distributor Facility Aware Date03/12/2020
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: 04/01/2020 Patient Sequence Number: 1
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