MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for ULTHERAPY SYSTEM, manufactured by Ulthera.
[99347614]
Got an ultherapy treatment it was sold as a no downtime "lunchtime face lift" with possibility of minor redness or light bruising that could be covered with makeup and was no big deal and that you could just go back to work the same day. The morning after the ultherapy treatment i looked like i had been the victim of a real bad beating. No possibility of covering this up with any makeup. My lower teeth and jaw continue to be extremely painful today and i was unable to return to work until (b)(6) 2018. There is no way i would have done the treatment if i were told this could happen!
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075103 |
| MDR Report Key | 7247489 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-02-05 |
| Date of Event | 2018-01-18 |
| Date Added to Maude | 2018-02-07 |
| 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 SYSTEM, |
| Generic Name | ULTHERA SYSTEM |
| Product Code | OHV |
| Date Received | 2018-02-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-06 |