MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-20 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[117689369]
Transducers involved in the treatment have not yet been returned and are currently awaiting shipment. When additional information regarding this event becomes available, a supplemental medwatch form will be filed.
Patient Sequence No: 1, Text Type: N, H10
[117689370]
On (b)(6) 2018, a merz affiliate emailed to report that a patient experienced a burn on the abdomen following an ultherapy treatment. On (b)(6) 2018, the affiliate stated that the patient may need a skin graft to resolve the burn. The patient was provided with unknown antibiotics and antiphlogistics (believed to refer to anti-inflammatory medication). Subsequently, on (b)(6) 2018, the affiliate reported a diagnosis of a third degree burn and confirmed the patient had undergone a skin graft on an unknown date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00008 |
| MDR Report Key | 7799815 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-20 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-07-07 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2016-08-30 |
| Date Added to Maude | 2018-08-20 |
| 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 | 2018-08-20 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| 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. Other; 2. Deathisabilit | 2018-08-20 |