MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-10-03 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[88027659]
The system support log was reviewed with no anomalies or warnings identified. Based on the support log review, the physical device has been requested for evaluation at this time. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This event was identified as being reportable as a result of a review of complaints received by ulthera, inc. Merz device innovation center. This submission is part of a correction documented in ulthera, inc. , merz device innovation center (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[88027660]
On (b)(6) 2017 a merz affiliate located in (b)(6) reported that a female patient had experienced sensory nerve pain three months post a full face ultherapy treatment administered with control unit serial number (b)(4). The patient was treated on (b)(6) 2016 with the standard recommended protocol with increased energy. The patient experienced a "shock like sensation" on the left side of her forehead during treatment but did not make the provider aware of the pain at the time of treatment. Three months later the patient sought treatment (physician name not provided) from a specialist because the "shock like sensation" did not subside. The specialist diagnosed the patient with trigeminal neuralgia and prescribed 300 mg of gabapentin for her symptoms. The affiliate reports the patient is 80% resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00007 |
| MDR Report Key | 6909733 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-10-03 |
| Date of Report | 2017-01-19 |
| Date of Event | 2016-09-24 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2015-12-15 |
| Date Added to Maude | 2017-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 AESTHETIC ULTRASOUND SYSTEM |
| Product Code | OHV |
| Date Received | 2017-10-03 |
| Returned To Mfg | 2018-08-23 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2017-10-03 |