MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-30 for CELLFINA SYSTEM CK-1 5036225 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[143671145]
The patient code was selected to be no code available as an appropriate code for the alleged outpouching does not exist. The lot number of the ck-1 in use during this treatment was not provided. The serial numbers of two cellfina motor modules were provided. The physician did not provide information on which of the motor modules were used during the treatment. An evaluation of the original dhr found that these two motor modules have no deviations and passed all tests. As the physician did not allege any malfunctions and since the motor modules do not have direct contact with the patient, these devices were not requested back for evaluation. The outpouching was reported to occur in an area where cellfina is not recommended to be used. The cellfina training recommends avoiding non-cellulite areas including anatomical junction points. The report contains no allegation of a malfunction and one cannot be confirmed. There is not enough information to confirm whether a device caused or contributed to the event. The physician was unable to judge whether the outpouching was permanent; however, the cellfina trainer alleged that the outcome will likely be permanent. Additional information was not provided despite multiple attempts. It should be noted, though the original date of awareness for the complaint is (b)(6) 2019, additional information was obtained on 1-april-2019 which led to the decision to file this report. Should additional information regarding this event become available, a supplemental medwatch form will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143671146]
On (b)(6) 2019, a merz affiliate forwarded a report from a physician who alleged that a patient had developed outpouching tissue on the thighs and hemosiderosis 3 months after a cellfina treatment. The treatment date was reported to be (b)(6) 2018. The physician reported performing very limited releases in the area. The sagging skin was stimulated with a fiber optic endolaser after discovering the outpouching of the left banana roll.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2019-00005 |
| MDR Report Key | 8566906 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-30 |
| Date of Report | 2019-02-28 |
| Date of Event | 2018-06-12 |
| Date Added to Maude | 2019-04-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | CELLFINA SYSTEM |
| Generic Name | CELLFINA SYSTEM |
| Product Code | OUP |
| Date Received | 2019-04-30 |
| Model Number | CK-1 |
| Catalog Number | 5036225 |
| Device Availability | N |
| 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. Other | 2019-04-30 |