MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-10-03 for ULTHERA SYSTEM UC-1 5036001 manufactured by Ulthera, Inc., Merz Device Innovation Center.
[87999510]
This event was identified as being reportable as a result of a review of complaints received by ulthera, inc. Merz device innovation center. This submission is part of a correction documented in ulthera, inc. , merz device innovation center (b)(4). If additional information should become available, a supplemental medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[87999771]
On (b)(6) 2015, a merz field representative conveyed that they received a call from a practice who reported a patient experiencing extreme paresis following a full face ulthera treatment with control unit serial number (b)(4), performed under standard protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2017-00014 |
| MDR Report Key | 6909706 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-03 |
| Date of Report | 2015-11-30 |
| Date of Event | 2015-10-19 |
| Date Mfgr Received | 2015-11-30 |
| Device Manufacturer Date | 2015-03-07 |
| Date Added to Maude | 2017-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MES 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 | 2017-10-03 |
| Model Number | UC-1 |
| Catalog Number | 5036001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-10-03 |