MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2017-06-29 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[78763688]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Device serial number unknown.
Patient Sequence No: 1, Text Type: N, H10
[78763689]
A patient's family member reported via a public social media posting that a family member experienced retinal nerve damage after receiving ultherapy treatment (serial number not provided, treatment provider not provided).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00010 |
| MDR Report Key | 6679468 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-04 |
| Date Mfgr Received | 2017-06-04 |
| Date Added to Maude | 2017-06-29 |
| 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 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 | ULTHERA SYSTEM |
| Generic Name | ULTHERA SYSTEM |
| Product Code | OHV |
| Date Received | 2017-06-29 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Lot Number | NA |
| 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 | 2017-06-29 |