MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-10-25 for CELLFINA CA1 manufactured by Ulthera Inc, Merz Device Innovation Center.
[58353179]
Past use life, disposed of.
Patient Sequence No: 1, Text Type: N, H10
[58353180]
A female patient treated (b)(6) 2016 was reported to (b)(6) on (b)(6) 2016 to have hard visible nodules the size of a quarter on the tissue in the area that was treated with cellfina. Follow up with the practice indicated the nodules were not painful and did not move. The patient is slowly resolving and at 6 months ((b)(6) 2016) the practice reported the lumps had gotten smaller but are still present. Treatment mapping and photos were requested for review but not submitted by the practice. The patient is gradually resolving but not fully resolved in a reasonable timeframe. No device malfunction or user error suspected. Per cellfina ifu, induration is an expected treatment event that can take 2+ years to fully resolve based on clinical evaluations. Will update this submission when patient has 100% resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2016-00011 |
| MDR Report Key | 6055542 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-10-25 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-01-05 |
| Date Mfgr Received | 2016-02-11 |
| Date Added to Maude | 2016-10-25 |
| 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. KELLIE WILES |
| Manufacturer Street | 1840 SOUTH STAPLEY DR SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4803361788 |
| Manufacturer G1 | ULTHERA INC, MERZ DEVICE INNOVATION CENTER |
| Manufacturer Street | 1840 SOUTH STAPLEY DR, SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85204 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLFINA |
| Generic Name | CELLFINA |
| Product Code | OUP |
| Date Received | 2016-10-25 |
| Model Number | CA1 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA INC, MERZ DEVICE INNOVATION CENTER |
| Manufacturer Address | 1840 S STAPLEY DR SUITE 200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-25 |