TRANSCRANIAL MAGNETIC STIMULATION OCD HELMET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-08 for TRANSCRANIAL MAGNETIC STIMULATION OCD HELMET manufactured by Brainsway Ltd..

MAUDE Entry Details

Report NumberMW5090272
MDR Report Key9167072
Date Received2019-10-08
Date of Report2019-10-07
Date of Event2019-01-14
Date Added to Maude2019-10-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRANSCRANIAL MAGNETIC STIMULATION OCD HELMET
Generic NameTRANSCRANIAL MAGNETIC STIMULATOR
Product CodeQCI
Date Received2019-10-08
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBRAINSWAY LTD.


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit 2019-10-08

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