MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-25 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[80987777]
If additional information should become available, a supplemental medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[80987778]
On (b)(6) 2017 a (b)(6) field representative received an email making them aware of a female patient who received an ultherapy treatment on (b)(6) 2016 with device serial number (b)(4). Patient alleges that as a result of the treatment, she developed left-sided severe edema, erythema, and discomfort starting in the chest wall and moving up the left side of her neck. Patient sought medical treatment on (b)(6) 2016 for neck stiffness, redness and warmth. Subsequent blood tests revealed elevated white blood cell count. A ct scan (date unknown) demonstrated extensive myositis and intramuscular edema. Patient alleges that she experienced a disruption of the integrity of her skin leading to a bacterial infiltration along the muscle and skin levels causing a myositis and cellulitis and a third-degree burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00011 |
| MDR Report Key | 6742770 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-25 |
| Date of Report | 2017-06-27 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2017-06-27 |
| Device Manufacturer Date | 2015-11-23 |
| Date Added to Maude | 2017-07-25 |
| 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 | 4803361756 |
| 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 | 2017-07-25 |
| Returned To Mfg | 2018-10-18 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Lot Number | 15C112323 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-07-25 |