MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. RADIESSE INJECTABLE IMPLANT; IMPLANT, DERMAL, FOR AESTHETIC USE

Model Number	8071M0K2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event of cellulitis was assessed as expected and possibly related to radiesse.Based on the information provided, the case was assessed as reportable to the us fda as the event of cellulitis 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.The device history record of radiesse dermal filler lot number 100120759 was reviewed.No nonconformances were noted that would have contributed to this event.A lot search was conducted on the reported lot and no other reports had been received on this lot number.
Event or Problem Description
This spontaneous report was received from a healthcare provider (hcp) via a merz sales representative concerning a (b)(6) female patient who received radiesse.Relevant medical history included well controlled hypothyroidism and periodic radiesse injections since 2014 without any adverse effect.Concomitant medications included synthroid 75 mcg.In 2019 the hcp injected the patient with 1.5 ml of radiesse into the face to achieve symmetry of her face.It was noted that most of the radiesse was injected into the lower part of the middle third and into the upper part of the lower third of her face with more of the radiesse injected in the left side of the face (than in the right side) since the left side presented a greater degree of sagging.No blockage was performed with anesthesia instead ice was applied before performing the different punctures.On (b)(6) 2019 the patient stated that the left side of her face felt hot and she experienced pressure.The patient returned to the clinic on (b)(6) 2019 at which time there was bruising on the left side of her face.The hcp examined that patient and diagnosed the patient with cellulitis in the left hemicara that extended from the lower third to the middle third of the face specifically to the zygomatic arch.The nose wing area was intact.At approximately 10 oclock am the patient was treated with 400 mg ciprofloxacin in 200 ml of distilled water 5 percent and 125 mg solumedrol bolus.Both medications were administered intravenously.The patient was asked to return at 4 oclock pm to receive another intravenous dose of ciprofloxacin.The hcp prescribed the patient 500 mg tablets twice a day and a medrol dose pack.After more than 30 days post procedure the cellulite was resolved but the large bruising on the left hemicara which was described as looking like a stain of port wine was not resolved.The lot number was reported as 100120759 with expiry date 09 may 2022.

• Brand Name: RADIESSE INJECTABLE IMPLANT
• Common Device Name: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney street; suite 10; franksville WI 53126
• MDR Report Key: 9252755
• Report Number: 3013840437-2019-00012
• Device Sequence Number: 13996276
• Product Code: LMH
• UDI-Device Identifier: M2138071M0K25
• UDI-Public: +M2138071M0K25/$$3220509100120759/
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P050052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: 8071M0K2
• Device Catalogue Number: 8071M0K2
• Device Lot Number: 100120759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR