FDA Adverse Event Injury Summary report: N

NOVIELLE VF GEL & GELPLUS

MDR report key: 1552159 · Received December 3, 2009

Report

Report Number: 3003644133-2009-00034
Event Type: Injury
Date Received: December 3, 2009
Date of Event: August 26, 2009
Report Date: November 3, 2009
Manufacturer: COAPT SYSTEMS, INC.
Product Code: MCK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NOVIELLE VF GEL & GELPLUS	EAR, NOSE & THROAT SYNTHETIC POLYMER	MCK	COAPT SYSTEMS, INC.	24601	02634

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other