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 2018-10-08 for THE CELLFINA SYSTEM CM1 5036029 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[123063081]
Additional information has been requested from the practice. The device is expected to be returned following communication with the practice on (b)(6) 2018. Following device evaluation activities, a supplemental medwatch form will be filed.
Patient Sequence No: 1, Text Type: N, H10
[123063082]
On (b)(6) 2018, ulthera, inc. , merz device innovation center became aware via email of a patient who was experiencing "keloid scarring" at "entry points" following a cellfina treatment performed on (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00009 |
| MDR Report Key | 7944859 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2018-10-08 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-05-29 |
| Date Mfgr Received | 2018-09-10 |
| Device Manufacturer Date | 2016-03-18 |
| Date Added to Maude | 2018-10-08 |
| 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 | 2018-10-08 |
| Returned To Mfg | 2018-10-09 |
| Model Number | CM1 |
| Catalog Number | 5036029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-10-08 |