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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 93336
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description

Per the clinic, the patient experienced recurrent infections at the abutment site. Subsequently, the patient had the abutment removed. Additional information has been requested but has not been made available as of the date of this report.

 
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Brand NameBA400 ABUTMENT 12MM
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 Key10660561
MDR Text Key211020460
Report Number6000034-2020-02890
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 12/02/2020,11/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number93336
Device Catalogue Number93336
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/02/2020
Distributor Facility Aware Date11/09/2020
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: 10/12/2020 Patient Sequence Number: 1
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