BIA400 IMPLANT 4MM W ABUTMENT 8MM 93330 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for BIA400 IMPLANT 4MM W ABUTMENT 8MM 93330 NA manufactured by Cochlear Ltd.

Event Text Entries

[186669955] This report is submitted on march 31, 2020.
Patient Sequence No: 1, Text Type: N, H10


[186669956] Per the clinic, the patient experienced skin overgrowth at abutment site and subsequently underwent a procedure to remove excess skin and was treated with a topical antibiotic. The implanted device remains.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-01097
MDR Report Key9902075
Date Received2020-03-31
Date of Report2020-03-06
Report Date2020-03-31
Date Reported to FDA2020-03-31
Date Reported to Mfgr2020-03-06
Date Added to Maude2020-03-31
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIA400 IMPLANT 4MM W ABUTMENT 8MM
Generic NameCOCHLEAR BAHA CONNECT SYSTEM
Product CodeMAH
Date Received2020-03-31
Model Number93330
Catalog NumberNA
Lot NumberNA
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR LTD
Manufacturer Address1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, 2109 AS 2109


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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