MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-04-24 for ULTHERA SYSTEM UC-1 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[143036432]
No contact details for the treating practice were provided despite multiple attempts. As indicated in the description, the contact details of four healthcare providers have been supplied and subsequently contacted for additional information. The initial reporter is not included as the patient's name differs between her social media accounts and a letter from one of her healthcare providers. No code available was selected because no term is available for shrinking skull in combination with the other alleged head injuries that the patient claims to have resulted in spine disfigurement. When additional information regarding this event becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[143036433]
A patient event was reported via e-mail by a patient on (b)(6) 2019. This e-mail was forwarded to field events on (b)(6) 2019. The patient alleged swelling, a collapsed face, a receding hairline, gray hollows under the eyes, ptosis, a shrinking skull, deformed face, numbness, disfigurement of the cervical spine, and pain following an ultherapy treatment 3 years ago. The patient subsequently alleged developing bell's palsy in an e-mail on (b)(6) 2019. The treating practice was unable to be identified by the patient. Contact details of four of the patient's healthcare providers were supplied and additional details regarding the patient's condition have been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2019-00004 |
| MDR Report Key | 8547324 |
| Report Source | CONSUMER |
| Date Received | 2019-04-24 |
| Date of Report | 2019-06-17 |
| Date of Event | 2016-06-24 |
| Date Mfgr Received | 2019-06-17 |
| Date Added to Maude | 2019-04-24 |
| 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 CIOTTI |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 4808288875 |
| 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 | 2019-04-24 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-24 |