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

Device Problem Migration (4003)

Patient Problems Pain (1994); Rash (2033); Swelling (2091)

Event Date 04/11/2019

Event Type  Injury  

Event Description

I had one syringe radiesse filter at the union square dermatology on (b)(6) 2019.The name of the dr who injected the filler is (b)(6).The reason i visited her was to tone and improve the appearance of wrinkles under my chin area.She highly recommended radiesse and encouraged me to agree to have 3 syringes but i only agreed to one syringe.She injected one syringe of radiesse filler on two sides of my chin area and under my cheeks.Below is dr (b)(6) statement that i copied and pasted from the medical report that her office provided to me and written by her: "1 syringe of radiesse was diluted and 0.7ml of 1% lidocaine with epinephrine and then introduced via a cannula to her nlf, marionette lines, and mid-face, as seen in the diagram.(softfil micro-cannula, 27g 40mm length, lot #1709us-51)".After leaving her office, i began feeling pain and observing rashes around my mouth area.I noticed deformation on the left side due to a nodule lump - inner lump - inner upper side of the face, under the eye over the cheekbone.I began taking advil and tylenol to be able to function on my daily activities, work, and business trips.On (b)(6), i noticed a visible deformation on the left side on my face.A deformation was caused by a hard nodule lump on inner upper side of the face, under the left eye and over the cheekbone.I immediately called dr (b)(6) office and reported pain, discomfort, and facial deformation.On (b)(6), i visited her and was very upset and scared.She said that the radiesse filler has moved from my cheek area to under my left eye and created a nodule lump that appears as a deformation.She said she can dissolve the nodule lump by injecting vitrase.Below is dr (b)(6)'s statement that i copied and pasted from my medical report that was provided for me by her office."pt states that 2 days ago, she noticed a nodule right at her left upper medial cheek, adjacent to her tear trough.She has a similar nodule on her right side but this is less noticeable and deeper.This nodule likely formed after migration of her radiesse from her lower medial cheek upwards; 0.4ml vitrase infiltrated to the left upper medial cheek.Encouraged pt to massage and use warm compresses daily.Return in 1 week for reevaluation and possible infiltration of sts instead." my pain continued and the nodule lump still is visible and noticeable.On (b)(6), i called her office to let her know that my pain is preventing me to be productive and function on my daily activities.She prescribed antibiotic (doxycycline, monohydrate 100 mg - generic for adoxa) to be taken for one month.(b)(6), i visited dr (b)(6) again and she injected vitrace under my left eye over cheek bone again.Below is dr (b)(6)'s statement that i copied and pasted from my medical report that was provided for me by her office."she is s/p 1 treatment with vitrase 0.4ml with improvement in the nodule she feels on her left upper medial cheek / tear trough region.Given that vitrase has been working without issues, will continue another treatment.If she notices less improvement after this second treatment, consider sts in future.After verbal consent obtained, 0.4ml vitrase infiltrated into the left upper medial cheek.Encouraged pt to massage and use warm compresses daily.Return in 1 week for reevaluation.(b)(6), i had appt to see dr (b)(6) for another to dissolve the nodule / lump under my skin.She injected vitrase under my left eye again.I asked her for explanation regarding the right side nodule formation that she mentioned on my medical report of (b)(6).She did not respond my question.I asked if she had a chance to call the radiesse mfr and to discuss with them our experience and see what they have to say about the pain and deformation on my face.She said she already did.I asked her what they said about.She did not respond.Today, (b)(6), i am writing this report on fda medwatch page.Pain, facial deformation.Fda safety report id# (b)(4).

• Brand Name: RADIESSE FILLER
• Type of Device: IMPLANT, DERMAL FOR AESTHETIC USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.
• MDR Report Key: 8658593
• MDR Text Key: 147038638
• Report Number: MW5087043
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR