MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-05-09 for THE CELLFINA SYSTEM CK-1 5036030 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[144595106]
Attempts to contact the doctor to gather additional information regarding the event and if a device malfunction occurred during treatment were performed on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2019; however, no additional information was provided. A review of the shipping history indicated multiple cellfina systems were shipped to this customer, but it is unknown what device was used during treatment on this patient. As information linking the alleged scarring to a particular device, kit, or malfunction is not possible, device identification and evaluation cannot be performed. A review of the patient complaint trend analysis for the reported issue of "scar" found this condition has not occurred at a high enough frequency level to provide a signal at this time and will continue to be monitored. Although the initial information for this event was provided directly from the patient who received treatment, the treating office is listed as they were the appropriate contact for follow-up. Should additional information regarding this event become available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[144595107]
A patient alleged on (b)(6) 2019 that six months following cellfina treatment, she had 34 dark scars on the treatment spots of her buttocks and thighs. The patient attributed it to her skin type and alleged informing the doctor that her skin scars differently, but was reassured that the procedure would not scar. The patient reported having a laser procedure following the cellfina treatment in an attempt to reduce the visibility of the scars, but the scars became worse after the treatment. The patient also reported having previous liposuction performed in the area. The patient does not believe any malfunction occurred or that the procedure went wrong. Attempts to contact the doctor to gather additional information regarding the event occurred on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2019; however, no additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2019-00008 |
| MDR Report Key | 8596501 |
| Report Source | OTHER |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-10 |
| Date Mfgr Received | 2019-04-10 |
| Date Added to Maude | 2019-05-09 |
| 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 | 2019-05-09 |
| Model Number | CK-1 |
| Catalog Number | 5036030 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-05-09 |