MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-10 for THE CELLFINA SYSTEM CM-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[91789411]
Multiple attempts to gather treatment/medical records and a treatment strategy map from the healthcare provider were made on the following dates: (b)(6) 2017. When additional information regarding this event becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[91789412]
A merz field representative was made aware on 11-oct-2017 of an adverse event that occurred following a cellfina treatment. The practice states that the treatment occurred on (b)(6) 2017 on the lateral thigh area, and the following morning, the patient awoke with blisters. The patient has reached out to ulthera, inc. , merz device innovation center to report that she had a "major reaction" to her cellfina treatment and is experiencing "third degree burns" and "two giant ulcers... That will scar and require surgery. " the patient also reported that she had to take oral antibiotics and apply ointments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00020 |
| MDR Report Key | 7020107 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-10 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-10-11 |
| Date Mfgr Received | 2017-10-11 |
| Date Added to Maude | 2017-11-10 |
| 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 SUTIE 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 | 2017-11-10 |
| Model Number | CM-1 |
| Catalog Number | CM-1 |
| 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 | 2017-11-10 |