FDA Adverse Event
Injury
Summary report: N
JUVEDERM ULTRA PLUS
MDR report key: 1192116
·
Received October 7, 2008
Report
- Report Number
- 3005113652-2008-00061
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- PRINGY
- Product Code
- LMH
- PMA / PMN Number
- P050047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A DAY AFTER TREATMENT WITH JUVEDERM ULTRA PLUS IN THE NASOLABIAL FOLDS, THE PT AWOKEN TO A HEADACHE AND PAIN IN THE SCALP AREA, AS WELL AS DISCOMFORT SLIGHTLY ABOVE THE INJECTION SITE. THE PT ALSO EXPERIENCED SYMPTOMS OF EDEMA AND BRUISING AT THE INJECTION SITE. THE PT TOOK IBUPROFEN THAT HELPED WITH THE PAIN, BUT THAT WAS NOT PRESCRIBED. THE PHYSICIAN PRESCRIBED A MEDROL DOSEPAK (ROUTE: "PO") AND BELIEVES THAT IF TREATMENT WAS NOT GIVEN THEN THERE MAY BE HAVE BEEN WORSENING OF SYMPTOMS LEADING TO PERMANENT DAMAGE. ALL THE SYMPTOMS HAVE NOW RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JUVEDERM ULTRA PLUS | JUVEDERM | LMH | PRINGY | NA | HV30244057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |