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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92127
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on february 1, 2021.

 
Event Description

Per the clinic, the patient experienced an infection at the abutment site. The device was explanted under a general anaesthetic on (b)(6) 2020. A skin revision was also performed.

 
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Brand NameBIA300 IMPLANT 4MM W ABUTMENT 6MM
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 Key11256713
MDR Text Key229572173
Report Number6000034-2021-00089
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 02/01/2021,01/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92127
Device Catalogue Number92127
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2021
Distributor Facility Aware Date01/05/2020
Event Location No Information
Date Report TO Manufacturer01/05/2020
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: 01/31/2021 Patient Sequence Number: 1
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