FDA Adverse Event
Other
Summary report: N
ELEVESS
MDR report key: 1202892
·
Received October 17, 2008
Report
- Report Number
- 1223628-2008-00013
- Event Type
- Other
- Date Received
- October 17, 2008
- Date of Event
- August 30, 2008
- Report Date
- October 17, 2008
- Manufacturer
- ANIKA THERAPEUTICS, INC.
- Product Code
- LMH
- PMA / PMN Number
- P050033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT'S CONDITION IS CURRENTLY RESOLVED. THE BATCH RECORD, INCLUDING STERILITY TESTING RECORDS, WAS REVIEWED AND DID NOT REVEAL ANY ISSUES WITH THE ALLEGED PRODUCT LOT.
Description of Event or Problem · 1
SWELLING AND LUMPINESS ALLEGEDLY IN THREE WEEKS AFTER INJECTION AT THE INJECTION AREA. THE PATIENT WAS TREATED WITH FIVE UNITS OF HYALURONIDASE. AN UPDATE WAS RECEIVED THAT NOTED THE PATIENT EXPERIENCED SOME NODULES ERUPTION. THERE WAS NO OTHER MEDICATION ADMINISTERED AND THE PATIENT SYMPTOMS HAVE SINCE RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELEVESS | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | ANIKA THERAPEUTICS, INC. | V080010AC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NK | Required Intervention |