MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-08-28 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[160843233]
This report is currently related to an open litigation; therefore, attempts to contact the reporter, patient, and/or treatment practice are not possible at this time. Additionally, no device identifiers (e. G. Serial, lot numbers) or additional information related to this event have been provided at this time. When additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[160843254]
Information was received via fda medwatch on 29-jul-2019 regarding an adverse event to a patient following ultherapy. According to the report, "pt was administered ultherapy (focused ultrasound) to her entire face, in amounts far exceeding the recommendation of merz no. America, the company which markets the ultherapy device. Pt has suffered significant facial damage, including loss of fat of at least 80% of her facial fat. My client has suffered severe damage to her face, including significant loss of facial fat, intermittent blepharospasm, permanent hypoesthesia, chronic jaw pain, nasal valve collapse and breathing difficulty which has been attributed to ultherapy by dr (b)(6), a licensed, board certified plastic surgeon. " no additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2019-00018 |
| MDR Report Key | 8941127 |
| Report Source | OTHER |
| Date Received | 2019-08-28 |
| Date of Report | 2019-09-04 |
| Date of Event | 2016-11-01 |
| Date Mfgr Received | 2019-09-04 |
| Date Added to Maude | 2019-08-28 |
| 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 CIOTTI |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4808288875 |
| 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 | 2019-08-28 |
| 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 | 2019-08-28 |