NI ASKU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-17 for NI ASKU manufactured by Cochlear Bone Anchored Solutions Ab.

MAUDE Entry Details

Report Number6000034-2019-02409
MDR Report Key9333566
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-17
Date of Report2019-10-25
Date Mfgr Received2019-10-25
Date Added to Maude2019-11-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. KRISTEL KOHNE
Manufacturer Street1 UNIVERSITY AVENUE
Manufacturer CityMACQUARIE UNIVERSITY, NSW 2109
Manufacturer CountryAS
Manufacturer Postal2109
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNI
Generic NameCOCHLEAR BAHA VISTAFIX SYSTEM
Product CodeFZE
Date Received2019-11-17
Model NumberASKU
Catalog NumberASKU
Lot NumberASKU
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR BONE ANCHORED SOLUTIONS AB
Manufacturer AddressKONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-17

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