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 2017-10-03 for ULTHERA SYSTEM UC-1 87017 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[87965992]
Ulthera, inc. , merz device innovation center performed the investigation of the devices associated with this patient event. These devices include a control unit and handpiece that were received at the facility on (b)(6) 2015, as well as a transducer that was received at the facility on (b)(6) 2015. A support log review from the ulthera control unit found multiple instances of code j, as well as an instance of a missing log. Therapy tests/tcps were all functioning within normal ranges. Software issue could not be duplicated and all tests were passed. Acoustic power specification was found to be within specification. No image issues were found. If additional information should become available, a supplemental medwatch report will be submitted. This event was identified as being reportable as a result of a review of complaints received by ulthera, inc. Merz device innovation center. This submission is part of a correction documented in ulthera, inc. , merz device innovation center capa-(b)(4). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87965993]
A merz affiliate located in (b)(6) notified ulthera inc. , merz device innovation center on (b)(6) 2015 about a patient who allegedly experienced third-degree burns following an ultherapy treatment with transducer serial number (b)(4), handpiece serial number (b)(4), and control unit serial number (b)(4). The treatment was reportedly performed under anesthesia and resulted in scarring on the left cheek with swelling in the neck for approximately 10 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00013 |
| MDR Report Key | 6909760 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-10-03 |
| Date of Report | 2015-07-24 |
| Date of Event | 2015-07-23 |
| Date Mfgr Received | 2015-07-24 |
| Device Manufacturer Date | 2014-02-04 |
| Date Added to Maude | 2017-10-03 |
| 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 |
| 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 | 2017-10-03 |
| Returned To Mfg | 2015-10-13 |
| Model Number | UC-1 |
| Catalog Number | 87017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-10-03 |