MAUDE Adverse Event Report: ULTHERA INC. ULTHERA AESTHETIC ULTRASOUND SYSTEM; ULTHERAPY

Model Number	UC-1
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
This was the three month date of my ultherapy visit ((b)(6) 2016).The date the maximum results should have been observable.There was no change in the tone and tightness of my skin.In fact, my wrinkles had turned into creases.I waited 3 more months for a six-month set of pictures and even the employees (including the manager) agreed that there had been no improvement.When my baseline, three-month and six-month pictures were sent to ultherapy, they said i must have gained weight and basically "too bad." this needs to be recalled immediately because this is a very expensive procedure that does more harm than good.

• Brand Name: ULTHERA AESTHETIC ULTRASOUND SYSTEM
• Common Device Name: ULTHERAPY
• Manufacturer (Section D): ULTHERA INC.; mesa AZ
• MDR Report Key: 5973102
• Report Number: MW5064989
• Device Sequence Number: 11989152
• Product Code: OUP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: UC-1
• Device Catalogue Number: UC-1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/21/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LISINOPRIL; VITAMINS (CITRACAL)
• Patient Age: 69 YR
• Patient Weight: 57