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 2018-06-26 for THE CELLFINA SYSTEM CK-1 5036225 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[112454885]
The affiliate stated on (b)(6) 2018 that they are returning the device for investigation. When additional information regarding this device becomes available, a supplemental medwatch form will be filed.
Patient Sequence No: 1, Text Type: N, H10
[112454886]
A (b)(6) affiliate from (b)(6) received a report on (b)(6) 2018 regarding a cellfina blade. It was reported that after 25 releases, the blade broke. The affiliate stated that there were no disadvantages for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00006 |
| MDR Report Key | 7640073 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-06-26 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-05-22 |
| Date Mfgr Received | 2018-05-29 |
| Date Added to Maude | 2018-06-26 |
| 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 | 1803361457 |
| 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 | 2018-06-26 |
| Returned To Mfg | 2018-09-04 |
| Model Number | CK-1 |
| Catalog Number | 5036225 |
| Lot Number | 46401250 |
| Device Expiration Date | 2018-06-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-06-26 |