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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MECTA LLC MECTA SIGMA; ELECTROCONVULSIVE THERAPY DEVICE
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MECTA LLC MECTA SIGMA; ELECTROCONVULSIVE THERAPY DEVICE Back to Search Results
Model Number MECTA SIGMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Headache (1880); Pain (1994); Fecal Incontinence (4571)
Event Date 06/23/2023
Event Type  Injury  
Manufacturer Narrative
This complaint was from a medwatch report filed by a patient.According to the doctors, the mecta sigma device was working as expected to patients before, during and after the jeremy's ect treatments.The device passes all exhaustive internal start up and after treatment internal tests.Interview with the doctor disclosed the following: - the device worked very well, just as expected.- they tell all of their patients to not eat after midnight the night before and to empty their bowels in the morning before treatment.- very few patients can lose control of their bowels, but it can happen.
 
Event Description
Patient was recommended for ect (electroconvulsive therapy) treatment.The patient reports the following: 1) they had a severe headache post treatment and was given tramadol.2) they had fecal incontinence, pain up and down back and neck, and chest pain.Note: the patient has had their neck fused, herniated disc problems and other spinal issues in the past that is unrelated to the ect treatment.
 
Manufacturer Narrative
This complaint was from a medwatch report filed by a patient.According to the doctors, the mecta sigma device was working as expected to patients before, during and after the jeremy's ect treatments.The device passes all exhaustive internal start up and after treatment internal tests.Interview with the doctor disclosed the following: the device worked very well, just as expected.They tell all of their patients to not eat after midnight the night before and to empty their bowels in the morning before treatment.Very few patients can lose control of their bowels, but it can happen.Follow up report: new information has not been added or has become available.The original report is unaltered.Therefore, there is no changes to the event, the investigation, or the conclusion.The follow up is that the initial reporter has updated their contact information and has asked to remain confidential.Therefore, we have removed their contact information from our report.The original report had the wrong device product code.This has been corrected from gxc to qgh.
 
Event Description
Patient was recommended for ect (electroconvulsive therapy) treatment.The patient reports the following: they had a severe headache post treatment and was given tramadol.They had fecal incontinence, pain up and down back and neck, and chest pain.Note: the patient has had their neck fused, herniated disc problems and other spinal issues in the past that is unrelated to the ect treatment.
 
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Brand Name
MECTA SIGMA
Type of Device
ELECTROCONVULSIVE THERAPY DEVICE
Manufacturer (Section D)
MECTA LLC
19799 sw 95th ave.
suite b, building d
tualatin OR 97062
Manufacturer (Section G)
MECTA LLC
19799 sw 95th avenue
suite b, building d
tualatin OR 97062
Manufacturer Contact
19799 sw 95th ave.
suite b, building d
tualatin, OR 97062
5036126780
MDR Report Key18813097
MDR Text Key336616109
Report Number3020533-2024-00001
Device Sequence Number1
Product Code QGH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192834
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/21/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/29/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberMECTA SIGMA
Device Catalogue Number9438-5001
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/02/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MECTA SIGMA; MECTA SIGMA
Patient Outcome(s) Other;
Patient Age36 YR
Patient SexMale
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