FDA Adverse Event
Other
Summary report: N
HYDRELLE
MDR report key: 1880497
·
Received October 13, 2010
Report
- Report Number
- 1223628-2010-00123
- Event Type
- Other
- Date Received
- October 13, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 13, 2010
- Manufacturer
- ANIKA THERAPEUTICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- 050033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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
THE RN INJECTOR STATED THAT SHE INJECTED HER MOTHER IN THE NLFS AND STATED THAT HER MOTHER IS NOW HAVING AN ADVERSE REACTION. PT WAS ALSO INJECTED AND STATED THAT SHE IS ALSO HAVING AN ADVERSE REACTION. PT SAID THAT BOTH HER AND HER MOTHER REQUIRED MEDICAL INTERVENTION. SENT REQUESTS FOR ADD'L INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDRELLE | IMPLANT, DERMAL FOR AESTHETIC USE | LMH | ANIKA THERAPEUTICS, INC. | 685-015 | V080099BR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |