ULTHERAPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-21 for ULTHERAPY manufactured by Merz North America, Inc..

Event Text Entries

[117979799] I had ultherapy on (b)(6) 2016 at (b)(6) dermatology in (b)(6). I was a pt of dr (b)(6) for several years and it was her aesthetician, (b)(6), who performed the treatment. After the first two months, i began to have significant loss of facial volume. By 6 months, i had extreme facial wasting. Due to my alarm over the resulting sagging skin on my face and neck, an ulthera rep recommended a second ulthera treatment to tighten my skin. This second treatment was again performed by (b)(6), under the supervision of the ulthera rep on (b)(6) 2016. The second treatment resulted in facial scarring and significant textural damage. I had to undergo facial repair surgery, to include fat transfer, excess skin removal, and laser resurfacing. Ulthera, the merz company, has been notified on a number of levels of my resulting damage, including my plastic surgeon's efforts to communicate my damages to ulthera's field events office. The fda approved device has been devastating and irreparable effects in all areas of my life. I will never be the same after enduring the suffering that ultherapy has brought me and loved ones. Please remove this device from the market. Please save other women from being ruined by ultherapy.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5079272
• MDR Report Key: 7805162
• Date Received: 2018-08-21
• Date of Report: 2018-08-04
• Date of Event: 2016-03-17
• Date Added to Maude: 2018-08-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ULTHERAPY
• Generic Name: FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION
• Product Code: OHV
• Date Received: 2018-08-21
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MERZ NORTH AMERICA, INC.
• Manufacturer Address: 6501 SIX FORKS ROAD RALEIGH NC 27615 US 27615

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-08-21