MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-03 for THE CELLFINA SYSTEM CK-1 5036030 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[145648305]
An evaluation of the reported device could not be performed as it was discarded by the facility. The cellfina disposable kit lot number associated with this event was provided, and a lot complaint history review of the device found complaint levels on this lot to be less than 1%. A device history review was performed and devices met all requirements. No non-conformance's or other issues were observed that could have contributed to the reported issue. A trend analysis of the reported issue of "blade breaks" showed no signal has occurred within the past 12 months. Attempts to obtain additional information regarding the event were performed on (b)(6) 2019; however, no additional information is available at this time. Should additional information be obtained, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[145648306]
A customer reported on (b)(6) 2019 that the blade in two cellfina disposable kits broke about a minute into the procedure. This is report two of two. The blade did not break while inserted into the patient and there was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2019-00007 |
| MDR Report Key | 8579557 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-03 |
| Date of Report | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Device Manufacturer Date | 2018-01-26 |
| Date Added to Maude | 2019-05-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-05-03 |
| Model Number | CK-1 |
| Catalog Number | 5036030 |
| Lot Number | 2018011204 |
| Device Expiration Date | 2019-11-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-03 |