MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-07 for NOVIELLE VOICE GELPLUS 0.5CC 25301 manufactured by Coapt Systems, Inc..
[17148340]
In 2009, the physician injected 0. 5ccs of novielle voice gelplus into four parallel depressions around the glabellar lines, into the dermal / subcutaneous junction. The patient experienced a burning sensation and swelling for approximately 36 hours after injection. In 48 hours after injection, the patient experienced extreme tenderness at the injection sites. Three days later, the coapt systems medical advisor contacted the physician and recommended the prescription of celestone as an anti-inflammatory for continued swelling.
Patient Sequence No: 1, Text Type: D, B5
[17320627]
The novielle voice gelplus was not returned to the manufacturer for evaluation, therefore, a failure mode could not be determined. The novielle voice gelplus is intended for vocal fold augmentation. The batch record for this lot has been reviewed and 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003644133-2009-00012 |
| MDR Report Key | 1378293 |
| Report Source | 05 |
| Date Received | 2009-05-07 |
| Date of Report | 2009-04-07 |
| Date of Event | 2009-04-09 |
| Date Mfgr Received | 2009-04-07 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2009-05-13 |
| 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 | LINDA RUEDY, DIRECTOR |
| Manufacturer Street | 1820 EMBARCADERO ROAD |
| 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 GELPLUS 0.5CC |
| Generic Name | EAR, NOSE & THROAT SYNTHETIC POLYMER |
| Product Code | MCK |
| Date Received | 2009-05-07 |
| Model Number | 25301 |
| Catalog Number | 25301 |
| Lot Number | 02264 |
| Device Expiration Date | 2009-07-31 |
| 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 | 2009-05-07 |