MAUDE Adverse Event Report: ECT ; DEVICE, ELECTROCONVULSIVE THERAPY

Device Problem Unintended Collision (1429)

Patient Problem Brain Injury (2219)

Event Type  Injury  

Event Description

(b)(6) hosp failed to obtain medical reports from (b)(6) hosp in (b)(6) where i was struck by 2 vehicles causing mild traumatic brain injury with behavioral abnormalities which is common after a concussion when struck by vehicles as a pedestrian.The (b)(6) hosp failed to obtain my medical record from (b)(6) which i agreed that they could obtain.If they had followed the treatment advised by (b)(6) for mild traumatic injury they wouldn't have diagnosed me with bipolar and over medicated me along with ect which was severely disabled me.Fda safety report id# (b)(4).

• Brand Name: ECT
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• MDR Report Key: 9840651
• MDR Text Key: 184153845
• Report Number: MW5093794
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 35 YR
• Patient Weight: 82