MAUDE Adverse Event Report: EEG; ELECTROENCEPHALOGRAPH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/08/2016

Event Type  Injury  

Event Description

Only that i had an eeg done and that it hurt while the test was running although not supposed to hurt.It hurt on the side where the constant seizure activity on frontal lobe exists and doctors do not know why the pain occured.The pain was hard to explain.Like an electric shock but a bit worse.

• Brand Name: EEG
• Type of Device: ELECTROENCEPHALOGRAPH
• MDR Report Key: 6285518
• MDR Text Key: 66156806
• Report Number: MW5067536
• Device Sequence Number: 1
• Product Code: GWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR
• Patient Weight: 45