FISHER WALLACE STIMULATOR 2 MA FW-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for FISHER WALLACE STIMULATOR 2 MA FW-100 manufactured by Fisher Wallace Laboratories.

Event Text Entries

[28311768] Pt used a brain stimulator to stimulate neurochemical production. Experienced headaches and had a nightmares. Pt used a fisher wallace stimulator at least once between (b)(6) 2015 on a setting between 1 and 4 ma for anywhere from 1 to 20 minutes. Frequency: twice daily; route: transcranial. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5056948
MDR Report Key5148147
Date Received2015-10-07
Date of Report2015-10-07
Date of Event2015-10-03
Date Added to Maude2015-10-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameFISHER WALLACE STIMULATOR 2 MA
Generic NameCRANIAL STIMULATOR
Product CodeJXK
Date Received2015-10-07
Model NumberFW-100
Lot NumberPO-129
Device Expiration Date2015-10-04
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerFISHER WALLACE LABORATORIES
Manufacturer AddressNEW YORK NY 10022 US 10022


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-10-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.