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

Catalog Number 8063M0K1

Device Problem Malposition of Device (2616)

Patient Problems Ischemia (1942); Muscle Weakness (1967); Necrosis (1971); Pain (1994); Scarring (2061); Skin Discoloration (2074); Tissue Damage (2104); Tingling (2171); Numbness (2415); Vascular System (Circulation), Impaired (2572)

Event Date 11/23/2015

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 necessitating medical 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 device history record review for the reported lot was conducted.No non-conformances were discovered that would have contributed to this event.The reported events of ischemia and necrosis are addressed in the label.Not returned.

Event Description

A physician reported that a patient (demographics not provided) received radiesse injections to the nasal labial folds (nlf) for aesthetic purposes.Medical history and concomitant medications were not reported.On (b)(6) 2015, the patient was injected by a nurse into the nasal labial folds and experienced ischemia in the distribution of the artery.Affected areas were the left nostril, upper lip, and cheek.Further information was pending.Additional information was received from the physician via the field clinical specialist on 25-nov-2015.The female patient was injected using a cannula with 1.5cc of radiesse to the nlf.The patient has been injected "multiple, multiple times" since 2008 to the nlf.No blanching of the tissue was present at the time of injection.The patient reported tingling and numbness of the lip hours post injection with some noted muscle weakness.She was diagnosed at that time with a possible hematoma.On (b)(6) 2015, the patient was evaluated in the office presenting with ischemia of the oral mucosa, upper lip, left nlf, left nasal alar, and left cheek.The physician had made contact with a center for hyperbaric oxygen.Follow-up was received from the nurse injector on 01-dec-2015.The patient was a (b)(6) female with no significant medical history or concomitant medications.Radiesse+ was injected.On (b)(6) 2015, the nurse evaluated the patient in the office.At that time, the patient's pain was less and her cheek was more pink than grey.There was sloughing on the inside of the lip.On that same date, the patient underwent a hyperbaric oxygen treatment with subsequent improvement.The patient underwent two more treatments on (b)(6) 2015.On both dates, she was seen by the physicians only and the nurse injector had no further information regarding the patient's status following the treatments.Follow-up was received from the nurse on 04-dec-2015.The patient has received a total of 6-8 hyperbaric treatments to date.The most recent treatment was performed on (b)(6) 2015.There was necrosis of the left alar, right in the crease, and a little spot on the left nasal labial fold.In addition, the patient had a purplish color on the left cheek.At this time, there is nothing to debride.No other interventions/treatments are being given at this time.Follow-up was received on 14-dec-2015 from the office manager.It was thought that the patient will have minimal permanent scarring.

Event Description

Follow-up was received on 06-jan-2016 from the nurse.On an unknown date, the patient developed a herpetic infection in the wound.Treatment included valtrex (valaciclovir) with resolution.Due to the herpetic infection, the area was "more red".On (b)(6) 2015, the patient was seen in the office.No further treatment was being given.The patient was completely healed with no open areas remaining.No further information will be forthcoming.

• 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: 5316217
• MDR Text Key: 34071357
• Report Number: 2135225-2015-00099
• 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,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 06/15/2017
• Device Catalogue Number: 8063M0K1
• Device Lot Number: 100083897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• 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: 52 YR