FDA Adverse Event
Injury
Summary report: N
JUVEDERM ULTRA PLUS
MDR report key: 1051723
·
Received May 23, 2008
Report
- Report Number
- 3005113652-2008-00030
- Event Type
- Injury
- Date Received
- May 23, 2008
- Date of Event
- April 23, 2008
- Report Date
- April 29, 2008
- Manufacturer
- PRINGY
- Product Code
- LMH
- PMA / PMN Number
- P050047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AFTER TREATMENT WITH JUVEDERM ULTRA UNDER BOTH EYES, THE PT PRESENTED WITH EDEMA, ERYTHEMA AND A RASH AT TREATMENT SITES. THE PHYSICIAN DESCRIBED THE SKIN AS APPEARING TO HAVE A "JUICY" NATURE. THE PHYSICIAN USED INJECTABLE LIDOCAINE BEFORE THE TREATMENT. THE PHYSICIAN PRESCRIBED ORAL PREDNISONE, OMNICEF, AND LUNESTA. ALLERGAN WILL CONTINUE TO F/U WITH THE PHYSICIAN IN AN ATTEMPT TO ACQUIRE THE LOT #, WHICH THE PHYSICIAN HAS NOT YET PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JUVEDERM ULTRA PLUS | JUVEDERM | LMH | PRINGY | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention | MULTIVITAMINS| IBUPROFEN| ARNICA |