MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2017-08-25 for THE CELLFINA SYSTEM CM-1 5036029 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[83726969]
If additional information should become available, a supplemental medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[83726970]
Ulthera, inc. Became aware of a patient complaint on 8/01/2017 of a blog posting created on 7/14/2017. The patient alleges that they received a cellfina treatment (device serial number not provided) on (b)(6) 2017. In subsequent comments to her blog posting, the patient states that she experienced pain and bruising for which she sought subsequent treatment to have seroma/hematomas drained. The patient also states that she was prescribed an antibiotic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00012 |
| MDR Report Key | 6822692 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2017-08-25 |
| Date of Report | 2017-08-01 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-08-01 |
| Date Added to Maude | 2017-08-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 4803361756 |
| 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 | 2017-08-25 |
| Model Number | CM-1 |
| Catalog Number | 5036029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-08-25 |