MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-05-10 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[107958772]
Based on information provided by the treating practice, no issues with the device occurred during use. During the treatment the patient reported feeling warmth in the area of their dental implant while a blue transducer (per review of the system support log part number ut-2, serial number (b)(4)) was in use. The treating practice indicated they switched to a different transducer type, after which the patient reported no further warmth. The treating practice stated the patient's swelling had been reduced following the removal of the dental implant, but that the patient was now experiencing bruising and tenderness. Attempts to determine the contact information for the patient's dentist were performed on (b)(6) 2018; however, these attempts were unsuccessful. The transducer in use at the time of the report has been requested to be returned and a follow-up report will be submitted as additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[107958773]
On (b)(4) 2018, ulthera, inc. ,(b)(4) device innovation center became aware via email of a patient who reported developing swelling around a mental dental implant following an ultherapy treatment. The treatment date was reported as (b)(6) 2018 and the patient reported the event to their treating practice on (b)(6) 2018. The patient's initial report stated they experienced warmth around the dental implant during the treatment, and that two days following the treatment they experienced facial swelling "and very painful on dental implant side. " some time between (b)(6) 2018, the patient was prescribed antibiotics proactively, and had the dental implant removed by their dentist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00004 |
| MDR Report Key | 7505224 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-05-10 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-04-05 |
| Date Mfgr Received | 2018-04-09 |
| Device Manufacturer Date | 2016-04-14 |
| Date Added to Maude | 2018-05-10 |
| 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 | 2018-05-10 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. Other | 2018-05-10 |