MAUDE Adverse Event Report: FISHER WALLACE LABORATORIES FISHER WALLACE STIMULATOR 2 MA; CRANIAL STIMULATOR

Model Number FW-100

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Sleep Dysfunction (2517)

Event Date 10/03/2015

Event Type  Injury  

Event Description

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.

• Brand Name: FISHER WALLACE STIMULATOR 2 MA
• Type of Device: CRANIAL STIMULATOR
• Manufacturer (Section D): FISHER WALLACE LABORATORIES ; new york NY 10022
• MDR Report Key: 5148147
• MDR Text Key: 28311768
• Report Number: MW5056948
• Device Sequence Number: 1
• Product Code: JXK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/04/2015
• Device Model Number: FW-100
• Device Lot Number: PO-129
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR