FDA Adverse Event
Injury
Summary report: N
JUVEDERM ULTRA XC TSK US
MDR report key: 2192445
·
Received July 26, 2011
Report
- Report Number
- 3005113652-2011-00052
- Event Type
- Injury
- Date Received
- July 26, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 30, 2011
- Manufacturer
- ALLERGAN
- Product Code
- LMH
- PMA / PMN Number
- P050047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT TO FDA ON (B)(4) 2011.
Description of Event or Problem · 1
HEALTH PROFESSIONAL REPORTED AFTER INJECTION WITH TWO SYRINGES OF JUVEDERM ULTRA XC IN THE "FOREHEAD LINES" THE PT EXPERIENCED AN INFECTION AT THE INJECTION SITE. THE PT HAS RECEIVED TREATMENT WITH MINOCYLINE FROM A PHYSICIAN OTHER THAN THE INJECTOR, ARTHROTABS AND PREDNISONE FROM A PRIMARY CARE PHYSICIAN, AND AN UNK ANTIBIOTIC FROM A HOSPITAL EMERGENCY ROOM. THE TWO SYRINGES THE PT WAS TREATED WITH ARE FROM TWO DIFFERENT LOTS. SEE MW# 3005113652-2011-00051 FOR RELATED REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JUVEDERM ULTRA XC TSK US | LMH | ALLERGAN | NA | H24L625644 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R | MULTI-VITAMIN |