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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 Hearing Impairment (1881)
Event Date 10/30/2019
Event Type  Injury  
Manufacturer Narrative

This report is submitted on january 10, 2020.

 
Event Description

Per the clinic, the patient experienced poor performance with the device. The abutment was changed under a general anaesthetic on (b)(6) 2019. A skin revision was also performed.

 
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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
MDR Report Key9572389
MDR Text Key174471436
Report Number6000034-2020-00202
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
Report Date 01/10/2020,12/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2020
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
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2020
Event Location No Information
Date Report TO Manufacturer12/20/2019
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: 01/09/2020 Patient Sequence Number: 1
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