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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374)

Event Date 02/17/2016

Event Type  Injury  

Event Description

I was admitted for bipolar mood disorder at (b)(6) hospital in (b)(6).The psychiatrist proceeded with ect therapy without my consent.When i woke up i felt severe pain in my left shoulder.I was seeking help and no one helped me.Until a nurse that was finishing her shift offered to take me to the hospital.There the orthopedic surgeon saw a fracture and dislocated left shoulder.I was not aware since i was under anesthetic.

• Brand Name: ECT THERAPY
• Type of Device: ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B
• MDR Report Key: 18142221
• MDR Text Key: 328277583
• Report Number: MW5148153
• Device Sequence Number: 1
• Product Code: QGH
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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): Required Intervention; Disability; Hospitalization; Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Race: White