MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-28 for ULTHERAPY manufactured by Ulthera Inc..
[79024447]
I had ultherapy performed one time 5-6 years ago on my neck and lower face, and noticed after about a year skin of my neck started looking crepey, thin and with uneven muscle tone. Very disappointing and wish i had never done it. Had it performed at (b)(6) in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070722 |
| MDR Report Key | 6680339 |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-28 |
| Date of Event | 2013-06-01 |
| Date Added to Maude | 2017-06-30 |
| 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 | ULTHERAPY |
| Generic Name | ULTHERA SYSTEM |
| Product Code | OHV |
| Date Received | 2017-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-28 |