MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for ULTHERAPY manufactured by Merz North America, Inc..
[126429015]
I did a procedure called ultherapy and it melted my face, it burns til this day and i have lack of fat and now burn spots all over my face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081080 |
| MDR Report Key | 8042355 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-02 |
| Date of Event | 2016-10-07 |
| Date Added to Maude | 2018-11-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTHERAPY |
| Generic Name | FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION |
| Product Code | OHV |
| Date Received | 2018-11-05 |
| Device Expiration Date | 2016-10-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA, INC. |
| Manufacturer Address | 6501 SIX FORKS RD RALEIGH NC 27615 US 27615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-05 |