FDA Adverse Event
Injury
Summary report: N
JUVEDERM (VOLUME/CONCENTRATION UNK)
MDR report key: 1101892
·
Received August 7, 2008
Report
- Report Number
- 3005113652-2008-00050
- Event Type
- Injury
- Date Received
- August 7, 2008
- Date of Event
- July 4, 2008
- Report Date
- July 11, 2008
- Manufacturer
- PRINGY
- Product Code
- LMH
- PMA / PMN Number
- P050047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
AFTER TREATMENT IN THE NASOLABIAL FOLDS AND THE LIPS THE PT PRESENTED WITH HARD NODULES AT THE TREATMENT SITES AND WITHIN ONE CENTIMETER PROXIMITY OF THE TREATMENT SITES. THE PT WAS TREATED WITH HYALURONIDASE BY THE TREATING PHYSICIAN. THE PT WAS EXAMINED BY A NON TREATING PHYSICIAN WHO REPORTED THIS EVENT. THE CONTACT INFO FOR THE TREATING PHYSICIAN IS NOT AVAILABLE TO ALLERGAN AT THIS TIME AND ALLERGAN POLICY IS TO RESOLVE ALL DOUBT IN FAVOR OF REPORTING. ALLERGAN WILL CONTINUE TO FOLLOW UP FOR ADD'L INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JUVEDERM (VOLUME/CONCENTRATION UNK) | JUVEDERM | LMH | PRINGY | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |