ULTHERAPY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-27 for ULTHERAPY manufactured by Merz North America, Inc..

Event Text Entries

[176934959] Ultherapy injured me badly, my face complete melted off all the fat. I have nerve damage and scar tissue where the machine was applied on my full face. I have jaw issues and breathing problems, on antibiotics. My situation is getting worse and worse. I'm in and out of the hosp, the company is misleading, not honest and never disclosed that their device was not fda approved for a full face. I'm now currently in a lawsuit and they are calling their machine off label. Fda never approved this and for a full face. They do not let drs know this, this company merz should be put off of business and shut down completely. Please step in and help. This machine is not from the united states, it's (b)(6) that's letting this happen and stepping over the fda boundary's, please contact me for more info; my case is set for trial (b)(6) 2020. It's been almost 4 yrs of complete torture what this machine destroyed my life, my face, my job, social life, it's been the most painful experience that anybody can go through. Please stop it. Thank you, (b)(6), my case is in (b)(6). Please contact me. Thank you. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092554
• MDR Report Key: 9637061
• Date Received: 2020-01-27
• Date of Report: 2020-01-24
• Date of Event: 2016-11-02
• Date Added to Maude: 2020-01-28
• 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: 3

Device Details

• Brand Name: ULTHERAPY
• Generic Name: FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION
• Product Code: OHV
• Date Received: 2020-01-27
• Device Expiration Date: 2016-11-02
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MERZ NORTH AMERICA, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit	2020-01-27