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 2017-10-17 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[89572645]
Follow up inquiries to confirm device serial numbers and to obtain further information including patient treatment and medical records were sent on 19-sep-2017, 21-sep-2017, 22-sep-2017. If additional information should become available, a supplemental medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[89572646]
On (b)(6) 2017, a merz field representative was made aware via a phone call from a treatment provider that a patient had a hypertrophic scar in the shape of one line on the lateral upper neck following an ulthera treatment. The full face ulthera treatment occurred on (b)(6) 2016. The serial number of the device was obtained from customer records. On (b)(6) 2017, the patient informed her ulthera provider that she had a hypertrophic scar. The doctor recommended a silicone stretch sheet band-aid at that time. On (b)(6) 2017, the patient had a follow up appointment during which the provider determined that the scar was worsening and extending, turning into a keloid scar. The provider excised the hypertrophic scar on that day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00015 |
| MDR Report Key | 6957084 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-17 |
| Date of Report | 2017-09-18 |
| Date of Event | 2017-05-19 |
| Device Manufacturer Date | 2014-12-03 |
| Date Added to Maude | 2017-10-17 |
| 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 | 2017-10-17 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-10-17 |