MAUDE Adverse Event Report: MERZ ULTHERAPY; FOCUSED ULTRASOUND FOR TISSUE

Health Effect - Clinical Codes	Hair Loss (1877); Neurological Deficit/Dysfunction (1982); Seizures (2063); Tissue Damage (2104); Loss of Vision (2139); Burn, Thermal (2530); Electric Shock (2554)
Type of Reportable Event	Serious Injury
Event or Problem Description
Several months after ultherapy at (b)(6), i went into a seizure and my face went into tetanus and ripped off the skeleton.I was burned alive and self-electrocuting, as ultherapy uses an electric current and 170 degrees and disrupted the body's natural electricity.I burned alive for almost 2 years.I would have been dead of a stroke.Vision loss, fat, tissue loss, eyelids lashes gone, neurological issues, seizures, cns damage, 4th degree electrical burns.Unable to have children.

• Brand Name: ULTHERAPY
• Common Device Name: FOCUSED ULTRASOUND FOR TISSUE
• Manufacturer (Section D): MERZ
• MDR Report Key: 6222296
• Report Number: MW5067033
• Device Sequence Number: 13088956
• Product Code: OHV
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTC MEDS: BENADRYL.; RX MEDS: GABAPEPTIN FOR SEIZURES AND NERVE PAIN.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 43 YR
• Patient Weight: 50