FDA Adverse Event
Other
Summary report: N
HYDRELLE
MDR report key: 2001131
·
Received February 18, 2011
Report
- Report Number
- 1223628-2011-00006
- Event Type
- Other
- Date Received
- February 18, 2011
- Date of Event
- August 24, 2010
- Report Date
- February 18, 2011
- Manufacturer
- ANIKA THERAPEUTICS, INC
- Product Code
- LMH
- PMA / PMN Number
- 050033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
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 WAS INJECTED IN THE NLF'S ON (B)(6) 2010, A CYSTIC NODULE OCCURRED AT THE TIME OF THE INJECTION. THE PT DID NOT SEEK TREATMENT AT THE TIME. THE CYST CONTINUED TO ENLARGE GRADUALLY. THE PT WENT TO THE PHYSICIAN IN (B)(6) AND THE PHYSICIAN ASPIRATED THE CYST. PT IS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRELLE | IMPLANT, DERMAL FOR AESTHETIC USE | LMH | ANIKA THERAPEUTICS, INC | 685-015 | V090044BA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |