MAUDE Adverse Event Report: ECT DEVICE; ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B

Device Problem Use of Device Problem (1670)

Patient Problems Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Cognitive Changes (2551); Superficial (First Degree) Burn (2685); Increased Sensitivity (4538)

Event Type  Injury  

Event Description

I received a forced ect at (b)(6) as a child.The ect device was used on my genitals.See the official united nations investigation report: https://t.Co/npojqsum7t.While this act of abuse is not standard practice, i still suffer from the same physical and cognitive symptoms peers given ect by standard means experience because the body does not absorb electricity, it diffuses it, sending it through the entire nervous system and brain, regardless of entry location.The brainstem is particularly vulnerable to electrical injury https://doi.Org/10.1177%2f155005948902000208.I had no mental illness when given ect at age 15 now 62 it was given on legal genitals and head while awake and while put to sleep my symptoms are body aches, sensitivity to noise, lose train of thought, forget people i've meet forget my children names get lost going to places i've been many times pinprick headaches that last long enough to drop you to the floor fatigue.Formal documentation: circumstances of injury: treatment injury cover specialist: (b)(6) 2.Treatment injury criteria for acc to approve cover for a treatment injury claim, the following must apply: there must have been a personal injury, which occurred when you were seeking or receiving treatment from, or at the direction of, one or more registered health professionals the personal injury occurred as part of treatment the treatment can be shown to have directly caused the personal injury; and the personal injury is not excluded from cover (for example, the injury must not have been mainly due to an existing, underlying condition) 3.Acc's decision the following injuries/conditions were not identified as being related to treatment in this case: cognitive impairment and burn to penis this is because: this claim is about electroconvulsive treatment at (b)(6) hospital in 1975.Fda safety report id# (b)(4).

• Brand Name: ECT DEVICE
• Type of Device: ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B
• MDR Report Key: 15242754
• MDR Text Key: 298231753
• Report Number: MW5111538
• Device Sequence Number: 1
• Product Code: QGH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Male