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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Device Problem Expulsion (2933)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on may 29, 2020.

 
Event Description

Per the patient, she experienced a protrusion of the internal magnet through the skin. The implant remains in-situ.

 
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Brand NameASKU
Type of DeviceCOCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
MDR Report Key10099849
MDR Text Key193007729
Report Number6000034-2020-01387
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 08/26/2020,08/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2020
Distributor Facility Aware Date08/03/2020
Event Location No Information
Date Report TO Manufacturer05/11/2020
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: 05/29/2020 Patient Sequence Number: 1
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