FDA Adverse Event
Other
Summary report: N
HYDRELLE
MDR report key: 1943630
·
Received December 13, 2010
Report
- Report Number
- 1223628-2010-00131
- Event Type
- Other
- Date Received
- December 13, 2010
- Date of Event
- October 18, 2010
- Report Date
- December 13, 2010
- Manufacturer
- ANIKA THERAPEUTICS, INC
- Product Code
- LMH
- PMA / PMN Number
- 050033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PER PRODUCT LABELING, THE PRODUCT IS INDICATED FOR USE IN THE MID TO DEEP DERMIS FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS SUCH AS NASOLABIAL FOLDS.
Description of Event or Problem · 1
PT HAD BILATERAL NLF AND JOWL AREA ON (B)(6) 2010. A VITRASE INJECTION WAS GIVEN ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRELLE | IMPLANT, DERMAL FOR AESTHETIC USE | LMH | ANIKA THERAPEUTICS, INC | 685-015 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |