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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 Host-Tissue Reaction (1297)
Event Date 06/19/2020
Event Type  Injury  
Manufacturer Narrative

This report is submitted on september 3, 2020.

 
Event Description

Per the clinic, the patient experienced a skin overgrowth on the abutment. The patient was placed under a general anaesthetic on (b)(6) 2020, in order to remove the excess skin and replace the abutment. The implanted device remains.

 
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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
Manufacturer Contact
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10486269
MDR Text Key205459330
Report Number6000034-2020-02299
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2017
Device MODEL Number92127
Device Catalogue Number92127
Device LOT Number123370
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/02/2020 Patient Sequence Number: 1
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