MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-03 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[91056042]
A follow up inquiry was sent on (b)(6) 2017 to the reporter listed in medwatch letter mw5072133. The response received was from a different individual, believed to be the patient, from whom a prior complaint had been received. Subsequently reached out on (b)(6) 2017 to the prior treatment provider via the merz (b)(4) affiliate. The treatment provider did not indicate that additional treatments had been provided to the patient and they were not able to substantiate the serious injury claims.
Patient Sequence No: 1, Text Type: N, H10
[91056043]
On (b)(6) 2017, merz product safety received a letter from fda's medwatch program ( mw5072133) regarding a patient who is allegedly experiencing adverse events post ultherapy treatment. The patient reported the following: "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. Its 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
| Report Number | 3006560326-2017-00019 |
| MDR Report Key | 7001294 |
| Report Source | CONSUMER |
| Date Received | 2017-11-03 |
| Date of Report | 2017-10-04 |
| Date of Event | 2015-05-12 |
| Date Mfgr Received | 2017-10-04 |
| Device Manufacturer Date | 2011-04-21 |
| Date Added to Maude | 2017-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JESSICA WARD DYKSTRA |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4803361457 |
| Manufacturer G1 | ULTHERA, INC., MERZ DEVICE INNOVATION CENTER |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTHERA SYSTEM |
| Generic Name | ULTHERA SYSTEM |
| Product Code | OHV |
| Date Received | 2017-11-03 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA, INC., MERZ DEVICE INNOVATION CENTER |
| Manufacturer Address | 1840 SOUTH STAPLEY DRIVE SUITE 200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-03 |