MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-10-25 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[90285146]
The initial notification of this event described use of rf gel which is in conflict with the instructions for use which calls for ultrasound gel. The devices (control unit, handpiece, and multiple transducers) have been requested back for evaluation but have not yet been returned. When additional information regarding this event becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[90285147]
On (b)(4) 2017, a merz field clinical specialist in (b)(4) became aware of a (b)(6) year old, female patient who experienced "inflammation and erythema or intense redness in the cheeks and neck" post treatment. "due to the inflammatory reaction, [the field clinical specialist] recommended applying local cold and 1% topical hydrocortisone cream and she provided the patient with a medical sample tube for the patient to apply uninterruptedly for 1 week at night. According to [the field clinical specialist], during the physical examination did not find any clinical data that could generate a reaction of this type; in the interview the patient reported that she had recently returned from (b)(6) and that she came "tanned" to the demonstration of the device. " on (b)(6) 2017, images were captured and then sent via email on (b)(6) 2017 indicating that the "patient is showing burned marks all around the face. " the field clinical specialist "recommended: application of local cold; use of topical steroids of type (hydrocortisone / betamethasone) for 8 to 10 days every 12 hours; soothing or desensitizing creams (cicabio arnica, roseliane cream, toleriane ultra fluid for sensitive skin, roseliac ar intense cream); the use of topical depigmentants (hydroquinone) is suggested at least 10 to 15 days after the noxious stimulus; remember that it is a transitory event and improves with the measures explained in the previous points. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00017 |
| MDR Report Key | 6978708 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-10-25 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-09-26 |
| Device Manufacturer Date | 2016-12-02 |
| Date Added to Maude | 2017-10-25 |
| 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 | 2017-10-25 |
| Returned To Mfg | 2018-03-13 |
| 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 | 2017-10-25 |