MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2018-08-01 for THE CELLFINA SYSTEM CK-1 5036030 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[115764548]
Multiple attempts to gather additional information including device serial/lot numbers and treatment/medical records have been made on 02-jul-2018, 13-jul-2018, 26-jul-2018, and 30-jul-2018 with no success. When additional information regarding this event becomes available, a supplemental medwatch form will be filed.
Patient Sequence No: 1, Text Type: N, H10
[115764549]
On (b)(6) 2018, a merz employee forwarded a report from a practice via email stating that a patient was experienced scarring post cellfina treatment. The practice stated that the patient's cellfina treatment was performed on (b)(6) 2017 and she has subsequently developed scarring. The scarring persists despite three fraxel treatments and three limelight treatments to alleviate it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00007 |
| MDR Report Key | 7741565 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-08-01 |
| Date of Report | 2018-07-02 |
| Date Mfgr Received | 2018-07-02 |
| Date Added to Maude | 2018-08-01 |
| 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 | THE CELLFINA SYSTEM |
| Generic Name | CELLFINA SYSTEM |
| Product Code | OUP |
| Date Received | 2018-08-01 |
| Model Number | CK-1 |
| Catalog Number | 5036030 |
| 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. Deathisabilit | 2018-08-01 |