FDA Adverse Event
Summary report: N
EVOLENCE COLLAGEN FILLER
MDR report key: 1879000
·
Received October 1, 2010
Report
- Report Number
- 3005654090-2010-00005
- Date Received
- October 1, 2010
- Date of Event
- May 1, 2009
- Report Date
- September 16, 2010
- Manufacturer
- COLBAR LIFESCIENCE LTD.
- Product Code
- LMH
- PMA / PMN Number
- 070013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FEMALE EXPERIENCED LUMPS AND BUMPS UNDER HER EYE AREA WHERE EVOLENCE WAS INJECTED 1.5 YEARS AFTER TREATMENT. THE AREA HAS BEEN TREATED WITH INJECTABLE LIDOCAINE AND SALINE, BUT SYMPTOMS DID NOT ABATE. PRODUCT IS NOT INDICATED FOR USE UNDER THE EYE; ONLY APPROVED TO TREAT NASOLABIAL FOLDS. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL, SIGNIFICANT INFORMATION IS RECEIVED. REPORT SENT TO FDA ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EVOLENCE COLLAGEN FILLER | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | COLBAR LIFESCIENCE LTD. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other | SYNTHROID |