MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-21 for ULTHERA AESTHETIC ULTRASOUND SYSTEM UC-1 manufactured by Ulthera Inc..
[55630057]
This was the three month date of my ultherapy visit ((b)(6) 2016). The date the maximum results should have been observable. There was no change in the tone and tightness of my skin. In fact, my wrinkles had turned into creases. I waited 3 more months for a six-month set of pictures and even the employees (including the manager) agreed that there had been no improvement. When my baseline, three-month and six-month pictures were sent to ultherapy, they said i must have gained weight and basically "too bad. " this needs to be recalled immediately because this is a very expensive procedure that does more harm than good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064989 |
| MDR Report Key | 5973102 |
| Date Received | 2016-09-21 |
| Date of Report | 2016-09-21 |
| Date of Event | 2016-06-01 |
| Date Added to Maude | 2016-09-23 |
| 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 |
| Brand Name | ULTHERA AESTHETIC ULTRASOUND SYSTEM |
| Generic Name | ULTHERAPY |
| Product Code | OUP |
| Date Received | 2016-09-21 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA INC. |
| Manufacturer Address | MESA AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-21 |