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 2018-05-01 for THE CELLFINA SYSTEM CK1-EU CK1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[107023227]
The device was discarded following the treatment, and as a result, an evaluation of the device is not possible. However, the facility reported the device functioned as intended during use. The investigation is currently ongoing and a follow-up report will be submitted when additional information is available.
Patient Sequence No: 1, Text Type: N, H10
[107023228]
On 06-apr-2018 a merz affiliate in (b)(6) became aware of a patient reported to have developed an infection post-cellfina treatment. The treatment date was reported as (b)(6) 2018 and the patient reported the infection on (b)(6) 2018. The patient had reportedly "played soccer [a few] days after the treatment. " the physician prescribed antibiotics on (b)(6) 2018; however, no improvement was reported. On (b)(6) 2018 a local antibiotic gel was applied, followed by a rinsing of the infection on (b)(6) 2018. A smear of the infection site was taken on (b)(6) 2018. The infection was "scraped out" on (b)(6) 2018 and a reduction of the infection was reported. Subsequent to these actions, it was reported the patient has a "dimple after the scraping (loss of tissue volume). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2018-00003 |
| MDR Report Key | 7477015 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-05-01 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-04-06 |
| Device Manufacturer Date | 2016-05-23 |
| Date Added to Maude | 2018-05-01 |
| 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 | THE CELLFINA SYSTEM |
| Product Code | OUP |
| Date Received | 2018-05-01 |
| Model Number | CK1-EU |
| Catalog Number | CK1 |
| Lot Number | 46401248 |
| Device Expiration Date | 2018-05-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-05-01 |