FDA Adverse Event
Other
Summary report: N
HYDRELLE
MDR report key: 1971873
·
Received January 18, 2011
Report
- Report Number
- 1223628-2011-00002
- Event Type
- Other
- Date Received
- January 18, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 18, 2011
- Manufacturer
- ANIKA THERAPEUTICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- 050033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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
PATIENT WAS INJECTED IN (B)(6) "2101" UNDER THE EYES AND IN THE LIPS. PT RETURNED TO THE DOCTOR ON (B)(6) 2011, WITH SWOLLEN LIPS AND A MASS UNDERNEATH. THE PT WAS TREATED WITH LASER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRELLE | IMPLANT, DERMAL FOR AESTHETIC USE | LMH | ANIKA THERAPEUTICS, INC. | 685-015 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |