ULTHERA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for ULTHERA manufactured by Merz.

Event Text Entries

[86313390] On approx of above date, i had ultherapy preformed on entire face and neck which i did not know, it was used off label, soon after treatment i noticed facial sagging etc, headaches, loss of vision in my right eye, constant fatigue, depression, anxiety, chronic sinusitis, dry eyes, drooping eyelids, herniated lower lids, which has worsened over the course of two and half years, i now am subject to an ulcer due to taken advil for the constant headaches, earaches, etc as well as horrible bruising and fractures due to the lack of hypodermis. Why is this machine not being regulated, it's been marketed for off label use, and possible adverse effects are not known nor discussed with patients, women 20, 30, 40 years old with facial wasting equal to an elderly person is unacceptable and horrifying, now my risks of developing autoimmune deficiency has risen as well as skin cancer, this dangerous machine needs to be pulled from market or possible adverse effects need to be explained to potential patients, you cleared this machine to be used on the public, without any regulations nor adequate monitoring.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5072133
• MDR Report Key: 6864644
• Date Received: 2017-09-13
• Date of Report: 2017-09-12
• Date of Event: 2015-04-22
• Date Added to Maude: 2017-09-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• 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: ULTHERA
• Generic Name: ULTHERA
• Product Code: OHV
• Date Received: 2017-09-13
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MERZ

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention; 2. Deathisabilit	2017-09-13