RADIESSE DERMAL FILLER

Report

Report Number: 2135225-2012-00059
Event Type: Other
Date Received: June 13, 2012
Date of Event: April 17, 2012
Report Date: May 16, 2012
Manufacturer: MERZ AESTHETICS, INC.
Product Code: LMH
PMA / PMN Number: P050052
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY RECORDS FOR RADIESSE LOT 1030761 WERE REVIEWED. ALL REQUIRED TESTING SPECIFICATIONS FOR THE LOT WERE MET PRIOR TO RELEASE AND THERE WERE NO ABNORMALITIES NOTED. NO ADD¿L INFO WAS PROVIDED BY DR. (B)(6), PRIOR TO REPORTING THIS EVENT.

Description of Event or Problem · 1

A PT WAS INJECTED WITH RADIESSE DERMAL FILLER TO THE PAN-CHECK AREA, ONE 1.5CC SPLIT BETWEEN EACH SIDE, ON (B)(6) 2012. DR.(B)(6) CALLED THE PT ON THE (B)(6) FOR FOLLOW-UP; THE PT REPORTED BRUISING AND SWELLING, CONSISTENT WITH HER PRIOR RADIESSE INJECTIONS. PT REPORTED NOTHING FROM (B)(6). PT CALLED DR. (B)(6) OFFICE ON (B)(6), REPORTING REDNESS AND SWELLING. SHE WAS UNABLE TO SEE PT ON THE (B)(6), SO NO PRESCRIPTION FOR AUGMENTIN WAS CALLED IN. ON (B)(6) ¿ PT SEEN BY DR. (B)(6), A BOGGINESS OF THE LEFT PAROTID GLAND, IRRITATION AND HURTS WHEN THE PT OPENS HER MOUTH. PT SENT TO ENT FOR A CT SCAN. ON (B)(6) ¿ PT REFERRED TO DR. (B)(6) (FACIAL P.S.) FOR MRI. PT PRESCRIBED MEDROL DOSE PACK, STARTED FEELING BETTER AFTER 1ST DOSE. ON (B)(6) ¿ PT CONCERNED THERE IS SWELLING BELOW THE AREA, NO PAIN WHEN MOUTH IS OPENED. ON (B)(6) ¿ PT COMPLAINED OF SWELLING GETTING WORSE. PRESCRIBED 40 MG PREDNISONE TO KEEP SWELLING STABLE AND CONTINUES AUGMENTIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RADIESSE DERMAL FILLER	RADIESSE INJECTABLE IMPLANT	LMH	MERZ AESTHETICS, INC.		1030761

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other