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 2019-03-05 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[137858448]
No contact details for the reporter are available, and records show that the complainant has not attempted to reach out to report this event despite the social media monitoring agency providing them with ulthera's contact details. The provider mentioned in the post was contacted twice by phone, the first time with the patient's initials (14-feb-2019) and the second with the patient's full name (18-feb-2019), and was not able to confirm treatment or knowledge of the patient. As additional information was not obtained, device identification, device evaluation, and support log review cannot be performed. The report contains no allegation of a malfunction and one cannot be confirmed. There is not enough information to confirm whether a device caused or contributed to the event. The report of "dent" was captured as tissue damage for the patient problem code in the interest of capturing the reported issue but in the absence of a formal diagnosis. Should additional information regarding this event become available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[137858449]
A social media monitoring agency reported via e-mail on 2/5/2019 that a patient alleged "ultherapy caused a permanent dent near my eye. I won an (b)(6) value door prize from (b)(6) dermatology and left with zero results and a noticeable dent" via (b)(6) post. No further information was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2019-00001 |
| MDR Report Key | 8391471 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-03-05 |
| Date of Report | 2019-02-05 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-03-05 |
| 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 | 2019-03-05 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Device Availability | N |
| 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. Deathisabilit | 2019-03-05 |