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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92126
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Unspecified Infection (1930)
Event Date 02/05/2021
Event Type  Injury  
Manufacturer Narrative

This report is submitted on march 12, 2021.

 
Event Description

Per the clinic, the patient experienced skin overgrowth and cellulitis at the abutment site which was treated with a topical antibiotic. During the abutment change on (b)(6) 2021. There was a skin revision under a general anaesthetic.

 
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Brand NameBIA300 IMPLANT 3MM 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 Key11468140
MDR Text Key239362319
Report Number6000034-2021-00683
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/12/2021,02/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92126
Device Catalogue Number92126
Device LOT NumberCOH1110775
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/12/2021
Distributor Facility Aware Date02/19/2021
Event Location No Information
Date Report TO Manufacturer02/19/2021
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: 03/11/2021 Patient Sequence Number: 1
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