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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 Expulsion (2933)
Patient Problem Wound Dehiscence (1154)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 02 march 2020.

 
Event Description

Per the clinic, the patient experienced wound breakdown at implant site and extrusion of the internal magnet subsequently the patient was treated with oral antibiotics. Clinical management is ongoing.

 
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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 Key9777023
MDR Text Key181801172
Report Number6000034-2020-00550
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,Followup
Report Date 04/09/2020,03/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2020
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? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/09/2020
Distributor Facility Aware Date03/13/2020
Event Location Hospital
Date Report TO Manufacturer04/09/2020
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: 03/02/2020 Patient Sequence Number: 1
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