MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-11-22 for ULTHERA SYSTEM UC-1 manufactured by Ulthera Inc., Merz Device Innovation Center.
[92835057]
The merz (b)(4) affiliate has made multiple attempts to gather treatment/medical records and a system support log from the customer. When additional information regarding this event becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[92835058]
A merz affiliate in (b)(4) was made aware on 26-oct-2017 of a potential adverse event that occurred following an ulthera treatment. The treating practice reported that a patient had a full face and neck treatment on (b)(6) 2017. On (b)(6) 2017, the practice was made aware that the patient had weakness of her left depressor labia inferioris muscle. The treating physician suspected a mandibular nerve injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00021 |
| MDR Report Key | 7054832 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-11-22 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2015-03-14 |
| Date Added to Maude | 2017-11-22 |
| 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 | 2017-11-22 |
| Model Number | UC-1 |
| Catalog Number | UC-1 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-11-22 |