MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-04-27 for THE CELLFINA SYSTEM CM-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[106792895]
The treating provider stated on (b)(6) 2018 that the device performed as intended during the treatment. A follow up was made on (b)(6) 2018, with no response to date regarding the serial numbers of the devices used during the treatment and the patient's current resolution status. When additional information becomes available regarding this event, a supplemental medwatch form will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[106792896]
Merz device innovation center was made aware via email of a reported adverse event on (b)(6) 2018. A patient reported bruising, swelling, dents, ripples/bulges, and "red and obvious" incision sites post cellfina treatment. The treatment was reported to have occured on (b)(6) 2017. The treating practice stated that the patient was treated with hyaluronic acid filler in an attempt to mitigate or resolve the reported adverse events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00002 |
| MDR Report Key | 7469942 |
| Report Source | CONSUMER |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-06 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-04-27 |
| 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 | MRS. 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 SUTE 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 | THE CELLFINA SYSTEM |
| Product Code | OUP |
| Date Received | 2018-04-27 |
| Model Number | CM-1 |
| Catalog Number | CM-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. Other | 2018-04-27 |