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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92129
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on 8 september 2020.

 
Event Description

Per the clinic, the patient experienced infections and skin overgrowth at abutment site; subsequently the patient was placed under general anaesthesia to undergo skin revision surgery and covert the patient to a transcutaneous osia baha implant system.

 
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Brand NameBI300 IMPLANT 4 MM
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
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 43533
SW 43533
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
MDR Report Key10500338
MDR Text Key205882943
Report Number6000034-2020-02478
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 09/08/2020,09/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92129
Device Catalogue Number92129
Device LOT Number89651
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/08/2020
Distributor Facility Aware Date08/21/2020
Event Location No Information
Date Manufacturer Received09/02/2020
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: 09/07/2020 Patient Sequence Number: 1
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