MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-15 for ULTHERAPY; AKA ULTHERA SYSTEM manufactured by Ulthera, Inc..
| Report Number | MW5088119 |
| MDR Report Key | 8793245 |
| Date Received | 2019-07-15 |
| Date of Report | 2019-06-11 |
| Date of Event | 2016-11-02 |
| Date Added to Maude | 2019-07-16 |
| 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 | ATTORNEY |
| 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; AKA ULTHERA SYSTEM |
| Generic Name | FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION |
| Product Code | OHV |
| Date Received | 2019-07-15 |
| Device Availability | * |
| 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. Deathisabilit | 2019-07-15 |