ULTHERAPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for ULTHERAPY manufactured by Merz North America, Inc..

Event Text Entries

[121864947] I received ultherapy on my face and neck. Was told it was non-invasive heated ultrasound to lift tighten and tone. Its main thing is to stimulate collagen. I was told only side effects could be mild discomfort and possibly not a noticeable difference. Results are supposed to show 3-6 month. At 2 months i noticed changes, by 4 months my face had been depleted of fat, and i? M left with deep hollows and nerve damage. I was told it doesn? T touch your fat layer. I? Ve since discovered it can, and heated ultrasound is actually used to deplete fat and destroy cells in other situations. I was also told it was fda approved, but later learned it is not for the face. It is advertised for entire face with no warning of nerve damage and fat loss. I? M physically and emotionally damaged. I? M scared of what else it? S done that can? T be seen as i have tugging, vibrating and aching feelings in face. I? Ve been to doctors multiple times and have been told i have nerve damage and am seeing a neurologist next week. I? M pregnant now and can't take recommended medication for pain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080133
• MDR Report Key: 7910517
• Date Received: 2018-09-25
• Date of Report: 2018-09-24
• Date of Event: 2018-02-27
• Date Added to Maude: 2018-09-26
• 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
• Product Code: OHV
• Date Received: 2018-09-25
• 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 RD RALEIGH NC 27615 US 27615

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-09-25