MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-15 for NOVIELLE, VS GEL manufactured by Co Apt System Inc..
[21594333]
I was injected with a filler in the nasal labial folds and marionette lines that i thought was hyaluronic acid and signed a consent to juvederm. A day later went out of the country and had an allergic reaction to the product with redness, swelling, burning painful cysts. I returned to the md and he tried to remove the product with a needle and gave me a script for pregnzone, a week later, my lower face started to swell so i returned to md and he attempted to remove more product. One week later, i returned because of burning and pressure as well as another one week later. I have scarring, granulomas, redness and painful area that are like cysts. Dates of use: 2008 (current). Diagnosis or reason for use: dermal filler. Event abated after use stopped or dose reduced: no. Event reappeared after reintroduction: no. Product therapy dates: late 2008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009635 |
| MDR Report Key | 1293708 |
| Date Received | 2009-01-15 |
| Date of Report | 2009-01-15 |
| Date of Event | 2008-11-24 |
| Date Added to Maude | 2009-02-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVIELLE, VS GEL |
| Generic Name | VF GEL REGULATION # 21 CFR 874.3620 CLASS II |
| Product Code | MIX |
| Date Received | 2009-01-15 |
| Lot Number | 24001 |
| ID Number | K080956 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CO APT SYSTEM INC. |
| Manufacturer Address | 1820 EMBARCADERO ROAD PALO ALTO CA 94303 US 94303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-15 |