FDA Adverse Event
Other
Summary report: N
HYDRELLE
MDR report key: 1833859
·
Received September 7, 2010
Report
- Report Number
- 1223628-2010-00117
- Event Type
- Other
- Date Received
- September 7, 2010
- Date of Event
- July 13, 2009
- Report Date
- August 31, 2010
- Manufacturer
- ANIKA THERAPEUTICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- 050033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DR. (B)(6) DID NOT REPORT THE COMPLAINT AT THE TIME OF THE ADVERSE EVENT ((B)(6) 2009) BECAUSE HE DID THINK THE PATIENT REACTION WAS RELATED TO HYDRELLE UNTIL HE RECEIVED ANOTHER PATIENT REACTION IN (B)(6) OF 2010. 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 DEVELOPED LATE INFECTION IN THEIR NASAL LABIAL FOLDS 6 MONTHS AFTER THE INJECTION. PATIENT ABSCESS INCISED AND DRAINED. AUGMENTIN WAS GIVEN TO THE PATIENT AND INFECTION RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRELLE | IMPLANT, DERMAL FOR AESTHETIC USE | LMH | ANIKA THERAPEUTICS, INC. | 685-015 | V080099AA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Required Intervention |