FDA Adverse Event
Other
Summary report: N
HYDRELLE
MDR report key: 1914314
·
Received November 17, 2010
Report
- Report Number
- 1223628-2010-00126
- Event Type
- Other
- Date Received
- November 17, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 17, 2010
- Manufacturer
- ANIKA THERAPEUTICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- 050033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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
ON (B)(6) 2010, A PT RECEIVED TOUCH-UP HYDRELLE IN THE SIDES OF THE MOUTH AND NLFS. THE PT RETURNED ON (B)(6) 2010 BECAUSE HE WAS SWOLLEN, DISTORTED, AND HAD PUSTULES NEAR THE INJECTION SITE. THE PT WAS PRESCRIBED PREDNISONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRELLE | IMPLANT, DERMAL FOR AESTHETIC USE | LMH | ANIKA THERAPEUTICS, INC. | 685-015 | UK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |