AXONICS 1201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for AXONICS 1201 manufactured by Axonics Modulation Technologies, Inc..

MAUDE Entry Details

Report Number3002968685-2020-00024
MDR Report Key9890793
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2019-10-02
Date Added to Maude2020-03-27
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 ContactPETER VU
Manufacturer Street26 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA
Manufacturer Phone9493364590
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAXONICS
Generic NameNEUROSTIMULATOR
Product CodeEZW
Date Received2020-03-27
Returned To Mfg2020-03-06
Model Number1201
Catalog Number1201
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAXONICS MODULATION TECHNOLOGIES, INC.
Manufacturer Address26 TECHNOLOGY DRIVE IRVINE CA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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