MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-23 for ULTHERA UC1 manufactured by Ulthera, Inc..
[70711301]
The system support log was reviewed with no warnings or error codes on the date of treatment. Support log review.
Patient Sequence No: 1, Text Type: N, H10
[70711302]
The health care provider reported 9/8/2016 that a patient had welts as a result of her (b)(6) 2016 chest treatment. As of 3/15/2017 the patient welts remain in the form of a scar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00005 |
| MDR Report Key | 6429757 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-23 |
| Date of Report | 2017-03-17 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-08 |
| Device Manufacturer Date | 2015-06-02 |
| Date Added to Maude | 2017-03-23 |
| 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 | KELLIE CERVANTES-WILES |
| Manufacturer Street | 1840 S STAPLEY DR STE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4803361788 |
| Manufacturer G1 | ULTHERA, INC. |
| Manufacturer Street | 1840 S STAPLEY DR, # 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 |
| Generic Name | ULTHERA CONTROL UNIT |
| Product Code | OHV |
| Date Received | 2017-03-23 |
| Model Number | UC1 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA, INC. |
| Manufacturer Address | 1840 S STAPLEY DR # 200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2017-03-23 |