Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER WALLACE LABS FISHER WALLACE CRANIAL NEUROSTIMULATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FISHER WALLACE LABS FISHER WALLACE CRANIAL NEUROSTIMULATOR Back to Search Results
Model Number FW-100
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problem Chest Pain (1776)
Event Type  Injury  
Event Description
Event information: "i actually did have some adverse reactions and had to stop using it.Although i had an improvement of mental symptoms the first day, i did however have prolonged chest pain following the use of it.I could only use it for one day because if i continued the use of it, i would continue to have chest pain and worse heart palpitations-irregular heartbeat.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FISHER WALLACE CRANIAL NEUROSTIMULATOR
Type of Device
CRANIAL NEUROSTIMULATOR
Manufacturer (Section D)
FISHER WALLACE LABS
630 flushing ave
brooklyn NY 11206
Manufacturer (Section G)
NANJING WATT ELECTRIC MOTOR CO. LTD.,
no. 2 yihu road, lishui
economic development zone,
nanjing, jiangsu 21120 0
CH   211200
Manufacturer Contact
gordon levites
630 flushing ave
brooklyn, NY 11206
8006924380
MDR Report Key16861992
MDR Text Key314479660
Report Number3006258094-2023-00012
Device Sequence Number1
Product Code QJQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K903654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 12/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model NumberFW-100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
-
-