MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-29 for CELLFINA CA1 manufactured by Ulthera Inc, Merz Device Innovation Center.
[41404865]
The device was not returned for investigation. The incident was reported after hte life of the device, therefore the was no device availabe to investigate.
Patient Sequence No: 1, Text Type: N, H10
[41404866]
Female patient treated (b)(6) 2015 was reported 12/8/2015 to demonstrate festooning of tissue. The treatment released 26 dimple total (13 on left buttock and 12 on the right buttock and 1 on right upper thigh). Slight oozing was documented immediately post- procedure, but no indolent infection as a contributing factor. As of (b)(6) 2016 the festooning persists. The practice feels clinically it looks like anetoderma. A biopsy was taken. Feedback from provider indicates that the instructions in the ifu may not have been followed specific to alternating depth and position of the handpiece. The treatment mapping was requested for review, however was misplaced by the practice.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2016-00003 |
| MDR Report Key | 5533049 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-29 |
| Date of Report | 2015-03-21 |
| Date of Event | 2015-01-14 |
| Date Mfgr Received | 2015-12-08 |
| Date Added to Maude | 2016-03-29 |
| 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 | KELLIE WILES |
| Manufacturer Street | 1840 S STAPLEY DR STE 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 S STAPLEY DR STE 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 | 2016-03-29 |
| 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 STE 200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-03-29 |