MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-05-22 for THE CELLFINA SYSTEM CK-1 5036225 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[108854154]
Multiple follow ups have been made to gather additional information including device serial numbers and treatment records on (b)(4) 2018, (b)(6) 2018. When additional information regarding this event becomes available, a supplemental medwatch form will be filed.
Patient Sequence No: 1, Text Type: N, H10
[108854155]
On (b)(6) 2018, an affiliate in italy forwarded a report from a physician who explained that a patient experienced a bulging of the subcutaneous fat that is visible on the skin surface due to a lack of support of the normal connective tissue (normal fibrous septae) following a cellfina treatment that occurred on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00005 |
| MDR Report Key | 7531683 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-06 |
| Date Mfgr Received | 2018-05-06 |
| Date Added to Maude | 2018-05-22 |
| 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 | 2018-05-22 |
| Model Number | CK-1 |
| Catalog Number | 5036225 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-05-22 |