FDA Adverse Event Injury Summary report: N

RADIESSE DERMAL FILLER

MDR report key: 1806822 · Received August 16, 2010

Report

Report Number: 2135225-2010-00049
Event Type: Injury
Date Received: August 16, 2010
Date of Event: July 29, 2010
Report Date: July 30, 2010
Manufacturer: MERZ AESTHETICS, INC. (FORMERLY BIOFORM MED, INC)
Product Code: LMH
PMA / PMN Number: P050052
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL INFO: CATALOG# 8069M0K1, LOT# 1019706, AND EXPIRATION DATE: 03/31/2010. DEVICE MFR DATE: 03/2010. THE ELONGATED DARKENED AREA OF SKIN WAS DIAGNOSED AS SUPERFICIAL NECROSIS WITH SMALL AREAS OF EROSION AT THE RIGHT ALAR REGION. DR (B)(6) (PT AND DERMATOLOGIST) TREATED THE AREA WITH NITROPASTE AND ANTIBIOTIC CREAMS. DURING FOLLOW-UP DR (B)(6) REPORTED HAVING A 3 MM DEFECT AREA AT THE JOINT OF THE ALAR AND NASO LABIAL FOLD. HE ANTICIPATES LITTLE TO NO SURFACE LOSS. HE STATED HE WAS USING THE ANTIBIOTIC CREAM, BIAFINE, A NON-STEROIDAL MEDICATION FOR TREATMENT OF BURNS AND WOUND CARE. LATER FOLLOW-UP FROM DR (B)(6) OFFICE MANAGER STATED THE AFFECTED AREA IS HEALING WELL. HE STILL HAS SLIGHT DISCOMFORT AND SOME DISCOLORATION BUT THE HEALING IS PROGRESSING NICELY. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE REPORTED LOTS; 1020003 AND 1019706 MET ALL SPECIFICATIONS PRIOR TO RELEASE.

Description of Event or Problem · 1

PT (DERMATOLOGIST) INJECTED WITH RADIESSE DERMAL FILLER IN THE NASO LABIAL FOLDS DEVELOPED AN ELONGATED AREA OF DARKENED SKIN WITH TENDERNESS AT THE RIGHT FOLD ONE DAY POST-INJECTION. A POSSIBLE VASCULAR OCCLUSION WAS SUSPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RADIESSE DERMAL FILLER	INJECTABLE IMPLANT	LMH	MERZ AESTHETICS, INC. (FORMERLY BIOFORM MED, INC)		1020003

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention