FDA Adverse Event
Injury
Summary report: N
ULTHERA
MDR report key: 2620870
·
Received June 8, 2012
Report
- Report Number
- 3006560326-2012-00003
- Event Type
- Injury
- Date Received
- June 8, 2012
- Date of Event
- May 9, 2012
- Report Date
- June 8, 2012
- Manufacturer
- ULTHERA INC.
- Product Code
- GEI
- PMA / PMN Number
- 072505
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
USER RECEIVED NUMEROUS CODE PROMPTS DIRECTING THEM "IF THE PROBLEM PERSISTS PLEASE SEE THE USERS MANUAL FOR FURTHER INFO OR CONTACT USER SUPPORT." USER DID NOT CONTACT ULTHERA USER SUPPORT UNTIL AFTER THE EVENT OCCURRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM WAS WORKING FINE AFTER HAVING ISSUES WITH UNKNOWN CODES. THE USER THEN EXPERIENCED THE SAME CODES AND FINALLY THE SYSTEM FROZE AND THE PT EXPRESSED PAIN. THE PT HAS A WELT ON THE CHEEK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTHERA | ULTHERA AESTHETIC ULTRASOUND SYSTEM | GEI | ULTHERA INC. | UC-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |