FDA Adverse Event
Injury
Summary report: N
JUVEDERM ULTRA
MDR report key: 1211086
·
Received October 24, 2008
Report
- Report Number
- 3005113652-2008-00066
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- January 9, 2008
- Report Date
- September 26, 2008
- Manufacturer
- PRINGY
- Product Code
- LMH
- PMA / PMN Number
- P050047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT TO FDA ON 10/24/2008.
Description of Event or Problem · 1
APPROX THREE WEEKS AFTER TREATMENT WITH JUVEDERM ULTRA IN THE NASOLABIAL FOLDS, CHIN AND UNDER A SCAR IN THE RIGHT CHEEK, THE AREA UNDER THE SCAR BECAME ITCHY, LUMPY, HOT, DRY AND HAD A "WELT-LIKE, X-SHAPED AREA". THE SYMPTOMS RESOLVED WITHIN THREE DAYS. THE PT WAS ALSO TREATED WITH BOTOX DURING THE SAME TREATMENT AND A COUPLE OF DAYS AFTER THE TREATMENT, THE PT PRESENTED WITH SYMPTOMS OF HOTNESS AND SWELLING AT THE LEFT SIDE OF THE NOSE WHERE THE BOTOX WAS USED. THE PT WAS PRESCRIBED ORAL ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JUVEDERM ULTRA | JUVEDERM | LMH | PRINGY | NA | HV24472854 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | PT HAD BOTOX DURING THE SAME TREATMENT. |