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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92128
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545)
Event Date 10/12/2020
Event Type  Injury  
Event Description

Per the clinic, the patient experienced an infection and skin irritation at the abutment site. Additional information has been requested but has not been made available as of the date of this report.

 
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Brand NameBI300 IMPLANT 3MM
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 Key10660212
MDR Text Key211016426
Report Number6000034-2020-02746
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 11/06/2020,10/18/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92128
Device Catalogue Number92128
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2020
Distributor Facility Aware Date10/15/2020
Event Location No Information
Date Report TO Manufacturer10/15/2020
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: 10/11/2020 Patient Sequence Number: 1
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