MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-23 for CELLFINA CK1 manufactured by Ulthera, Inc.
[70737355]
Ulthera medical director discussed use of compressive garments, massage, mud-wraps to absorb tissue fluid (for those that have access to this modality) could be applied as the solution for problem management. However, the patient is not returning for further follow-up. Dr. (b)(6) will send the patient a letter asking her to return and will itemize proposed treatments.? The device was unable to be investigated as it's a single use disposable. The practice did not record the lot number, therefore unavailable for this report (as well as the udi). If additional information should become available, a supplemental medwatch report will be sent accordingly. Device disposed, single use.
Patient Sequence No: 1, Text Type: N, H10
[70737356]
Ulthera, inc. Received a report on 2/23/2017 from a health care provider (hcp) stating that a patient currently under her care for endermologie treatment was concerned with the results from the patient's cellfina treatment received on (b)(6) 2016 from another practice. Ulthera, inc. Contacted the original hcp that treated the patient on (b)(6) 2016 and received information that the cellfina treatment for buttocks, posterior, lateral, and anterior thighs went smoothly and without event. The patient saw the original hcp for a follow-up visit on (b)(6) 2016 and demonstrated good result with no warning signs. A second follow-up visit was recommended in (b)(6) 2016, however the patient rescheduled to (b)(6) 2016 when the patient presented with some localized thighs deformities. During the (b)(6) follow-up visit, the patient stated that sometime between (b)(6), she had received endermologie treatment with a different hcp (the reporter). Later, the patient retracted that she was treated with endermologie during that time. Based on review of the original cellfina treatment records, initial follow-up results and current photos, it is suspected that the patient did receive endermologie in the areas she also received cellfina treatment. The endermologie treatment given to the same areas the cellfina treatment could potentially aggravate the initial subcissions from the cellfina treatment causing the localized swellings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00006 |
| MDR Report Key | 6429743 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-23 |
| Date of Report | 2017-03-16 |
| Date of Event | 2016-08-08 |
| Date Mfgr Received | 2017-02-23 |
| Date Added to Maude | 2017-03-23 |
| 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 | KELLIE CERVANTES-WILES |
| Manufacturer Street | 1840 S STAPLEY DR # 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4803361788 |
| Manufacturer G1 | ULTHERA, INC. |
| Manufacturer Street | 1840 S STAPLEY DR # 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 | CELLFINA |
| Generic Name | CELLFINA STERILE DISPOSABLE KIT |
| Product Code | OUP |
| Date Received | 2017-03-23 |
| Model Number | CK1 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA, INC |
| Manufacturer Address | 1840 S STAPLEY DR #200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-03-23 |