MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-11-01 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[90847371]
The treating provider does not believe that the reaction that the patient experienced is related to ultherapy, rather the numbing anesthetic cream used during both the mesotherapy and the ultherapy treatments. Should additional information become available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[90847372]
A merz affiliate in the (b)(4) was notified on (b)(6) 2017 about a female patient who had an allergic reaction following an ultherapy treatment conducted on (b)(6) 2017. Per the treating provider, the patient experienced a swollen mouth after the ulthera treatment and had to go to the hospital as a result of the reaction. The provider states that the patient had the same type of reaction with a mesotherapy treatment performed on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00018 |
| MDR Report Key | 6994861 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-11-01 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-10-03 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-11-01 |
| 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 |
| 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 | 2017-11-01 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Hospitalization; 2. Other | 2017-11-01 |