MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-03 for NOVIELLE VF GEL & GELPLUS 24601 manufactured by Coapt Systems, Inc..
[1253502]
It has been reported that the physician injected novielle gelplus into the cheeks and novielle gel into the marionette lines, nasolabial folds and pre-jowl in 2009. Firmness and redness was noted after the injections. The following month, the patient returned to the physician's office because of lumpiness, which was palpable, but not visible. Redness was noted in the tear trough region. Triamcinolone was prescribed. Two months later, an aesthetician noted the lumpiness and redness is now visible in the nasolabial folds, marionette lines and pre-jowl areas. Some redness is still visible in the cheek area.
Patient Sequence No: 1, Text Type: D, B5
[8499298]
The device was not returned to the manufacturer, therefore, an investigation to determine the root cause could not be conducted. Novielle gel and gelplus is cleared for vocal fold augmentation. The batch record for this lot has been reviewed, which contains no abnormal manufacturing events. The complaint rate for this device is not considered abnormal. If additional information becomes available, it will be submitted in a supplemental report. Additional model number: 25601. Additional catalog number: 25601. Additional lot number: 02633.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2009-00034 |
| MDR Report Key | 1552159 |
| Report Source | 05 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-11-03 |
| Date of Event | 2009-08-26 |
| Date Mfgr Received | 2009-11-03 |
| Device Manufacturer Date | 2009-04-01 |
| Date Added to Maude | 2009-12-10 |
| 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 | LOUIS MARCOUX, MGR. |
| 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 VF GEL & GELPLUS |
| Generic Name | EAR, NOSE & THROAT SYNTHETIC POLYMER |
| Product Code | MCK |
| Date Received | 2009-12-03 |
| Model Number | 24601 |
| Catalog Number | 24601 |
| Lot Number | 02634 |
| Device Expiration Date | 2010-02-28 |
| 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. Other | 2009-12-03 |