MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-06-08 for ULTHERA UC-1 manufactured by Ulthera, Inc. Merz Device Innovation Center.
[77175691]
Multiple attempts made to obtain support log from distributor. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[77175692]
A (b)(4) affiliate located in (b)(6) reported to ulthera. Inc, (b)(4) device innovation center on (b)(6)2017 a patient who is experiencing facial paralysis of the right side of the mouth hours post ultherapy treatment. The patient was treated on (b)(6) 2017 on the eye and cheek region. As of (b)(6) 2017 the physician reported to the affiliate that the patient is improving but is not fully resolved. Speech therapy and physiotherapy provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00008 |
| MDR Report Key | 6628912 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-06-08 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-05-04 |
| Device Manufacturer Date | 2012-04-26 |
| Date Added to Maude | 2017-06-08 |
| 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 DR SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4803361756 |
| Manufacturer G1 | ULTHERA INC, MERZ DEVICE INNOVATION CENTER |
| Manufacturer Street | 1840 SOUTH STAPLEY DR SUITE 200 |
| Manufacturer City | MESA AZ 85143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTHERA |
| Generic Name | ULTHERA AESTHETIC ULTRASOUND SYSTEM |
| Product Code | OHV |
| Date Received | 2017-06-08 |
| Model Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Deathisabilit | 2017-06-08 |