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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ECT MACHINE

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ECT MACHINE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109)
Event Date 08/03/2007
Event Type  Injury  
Event Description

Vaginal bleeding, tia, almost death. Diagnosis or reason for use: for stress due finances. Event abated after use stopped or dose reduced: yes; event reappeared after reintroduction: yes; route: yes.

 
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Brand NameECT MACHINE
Type of DeviceECT MACHINE
MDR Report Key5662262
MDR Text Key45525061
Report NumberMW5062350
Device Sequence Number1
Product Code GXC
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/10/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/10/2016 Patient Sequence Number: 1
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