MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-05 for NOVIELLE VOICE GEL PLUS 25301 manufactured by Coapt Systems, Inc..
[16922064]
It has been reported that the physician injected two syringes of novielle gel plus around the nasolabial folds and marionette lines on (b) (6) 2009. The pt developed painful lumps in the area of injection. The physician prescribed medication.
Patient Sequence No: 1, Text Type: D, B5
[17056416]
The device was not returned to the mfr; therefore, an investigation to determine root cause could not be conducted. Novielle gel plus is designed for vocal fold augmentation. If add'l info becomes available, it will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2010-00002 |
| MDR Report Key | 1652501 |
| Report Source | 05 |
| Date Received | 2010-04-05 |
| Date of Report | 2010-02-22 |
| Date of Event | 2009-03-19 |
| Date Mfgr Received | 2010-02-22 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GAIL STEWART, DIR. |
| Manufacturer Street | 1820 EMBARCADERO RD. |
| Manufacturer City | PALO ALTO CA 94303 |
| Manufacturer Country | US |
| Manufacturer Postal | 94303 |
| Manufacturer Phone | 6504617600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVIELLE VOICE GEL PLUS |
| Generic Name | EAR, NOSE & THROAT SYNTHETIC POLYMER |
| Product Code | MIX |
| Date Received | 2010-04-05 |
| Model Number | 25301 |
| Catalog Number | 25301 |
| Lot Number | 02402 |
| Device Expiration Date | 2009-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COAPT SYSTEMS, INC. |
| Manufacturer Address | PALO ALTO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-05 |