MAUDE Adverse Event Report: MERZ NORTH AMERICA RADIESSE+ DERMAL FILLER; INJECTABLE IMPLANT

Device Problem No Apparent Adverse Event (3189)

Patient Problems Cellulitis (1768); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event was deemed to meet serious injury criteria of necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additionally, the device was assessed as possibly causing or contributing to the event.The lot number was not reported.The reported events of suspected cellulitis and vascular occlusion are addressed in the label.

Event Description

A physician reported via a sales representative that a (b)(6) year old female received radiesse+ in the chin.Medical history included prior radiesse and hyaluronic acid fillers.Concomitant products were not reported.In (b)(6) 2015, approximately 7 days prior to report, the physician injected 1.5cc radiesse+ as three boluses to the chin.The next day, symptoms of discoloration and pain developed.On day 2, the patient was prescribed doxycycline.On day 3, pustules developed.The patient consulted with a dermatologist who suspected cellulitis and changed antibiotics (later identified as cephalexin).At the time of this report, the patient has a "pink patch" 3cm x 4cm with dark discoloration in the center.The physician referred patient for a plastic surgery consult and the plastic surgeon diagnosed a vascular occlusion.Additional information was received from the physician on (b)(6) 2016: the physician stated that patient was treated with local wound care, aquaphor, and aspirin.The area was still pink but "looks very good.".

• Brand Name: RADIESSE+ DERMAL FILLER
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA; 4133 country road; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA; 4133 country road; franksville WI 53126
• Manufacturer Contact: scott sykes, md ; 6501 six forks road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 5358379
• MDR Text Key: 35607734
• Report Number: 2135225-2016-00001
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR