MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-12-10 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[94349580]
Following the initial report, the treatment providers were contacted, however, they no longer work at the practice and do not have access to records in order to comment. The practice was contacted on (b)(6) 2017 and (b)(6) 2017 but to date has not provided any additional information or confirmed availability of the device or records associated to the device or treatment. When additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[94349581]
On (b)(6) 2017, a patient contacted ulthera, inc. , merz device innovation center and reported permanent scars, loose skin, and "concavities" following an ultherapy treatment on (b)(6) 2016. The patient also reported undergoing a prior ultherapy treatment on 2016-mar-17. The patient stated that she had fat grafting and a full face and neck lift to address the outcomes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00023 |
| MDR Report Key | 7102869 |
| Report Source | CONSUMER |
| Date Received | 2017-12-10 |
| Date of Report | 2017-11-11 |
| Date of Event | 2016-10-03 |
| Date Mfgr Received | 2017-11-11 |
| Device Manufacturer Date | 2013-05-31 |
| Date Added to Maude | 2017-12-10 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | 2017-12-10 |
| 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. Other | 2017-12-10 |