MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-11-23 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[128213021]
There was no allegation of a device malfunction. There are not enough details to confirm whether a merz/ulthera device caused or contributed to the event. The reported issues were deemed serious due to the use of antibiotics, following discussion with the merz medical director. The ulthera instructions for use document 1004125ifu rev. A states that "pain" is a potential side effect reported in the clinical evaluation of the ulthera system. No additional investigation or corrective actions are warranted for this complaint.
Patient Sequence No: 1, Text Type: N, H10
[128213022]
During a maude review on 10/27/2018, a merz employee found an adverse event report (mw5033696) that was reported to the fda by a patient on (b)(6) 2013. The patient reported the following: "my experience entailed an aesthetician mashing a rock hard plastic device into my face while it jackhammered sharp electric shocks into my skull. " the patient also reported that her treatment was the most painful experience she has ever had and she felt like her body had been through a terrible physical trauma, like she was hit in the face with a bat. The patient stated that she experienced debilitating exhaustion for nearly 3 weeks from all the pain in her skull, blinding migraines, and uncontrollable watery eyes. The patient also stated that due to the "physically traumatic experience", her lyme disease symptoms resurfaced and she had to start taking antibiotics again. The patient mentioned that the wrinkles under her eyes are more prominent that before the treatment. The adverse event report did not contain the patient's name or contact information and it did not list the treatment provider or location.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00010 |
| MDR Report Key | 8100005 |
| Report Source | OTHER |
| Date Received | 2018-11-23 |
| Date of Report | 2018-10-27 |
| Date Mfgr Received | 2018-10-27 |
| Date Added to Maude | 2018-11-23 |
| 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 | 2018-11-23 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Device Availability | N |
| 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 | 2018-11-23 |