• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERZ NORTH AMERICA, INC. RADIESSE INJECTABLE IMPLANT IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cyst(s) (1800)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, questionable granuloma / post-traumatic cysts, was deemed to meet serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage of a body structure. The device history record could not be reviewed as the lot number was not reported.
 
Event Description
This mdr is related to mdr 3013840437-2020-00118 and 3013840437-2020-00119, refering to the same patient. This spontaneous report was received from a (b)(6) physician and concerns a (b)(6) year-old female patient (b)(6). She was injected subdermally, with a total of 12 ml of radiesse®, into the temporal,parotideomasseteric, buccal, zygomatic and mental region, for temporal lifting, on (b)(6) 2020. She was injected with 6 ml per side (into 3 injection points per side), using the vector lifting technique. Radiesse® was diluted with 0. 9% nacl, in a 1:1 dilution ratio. A 22gx70 mm cannula was used for injection. The patient was previously treated with botox® and xeomin®, into the full face, in 2017 and in the spring of 2019. The patient was previously injected with belotero volume®, into the middle third of the face and with belotero soft®, into the forehead and wrinkles, in the autumn of 2019 and in (b)(6) 2020. She was previously injected with radiesse®, in 2014, 2017 and 2018. The patient was also previously treated with meso-wharton and mesoeye, in (b)(6) 2020. As reported, the patient tolerated all the procedures well, according to the rehabilitation period. The patients medical history included adrenal fatigue and vaginal candidiasis. Concomitant medication included etoxydol, sideral, vitamin d and vitamin c. According to the glogau classification, the patient was in group ii. She had no disposition to lymph drainage problems, allergies, autoimmune diseases, intake of interferon or omalizumab, or surgical interventions in the past. On (b)(6) 2020, one day after the treatment with radiesse®, the patient experienced pastosity of the face and accumulation of the product in the form of conglomerates, in the nasolabial fat packs and masticatory area. On (b)(6) 2020, as corrective treatment the patient received intravenous injections of calcium chloride (reported as no. 15), until (b)(6) 2020, intravenous injections of sodium thiosulfate (reported as no. 15), until (b)(6) 2020, ethoxidol, 200 mg per day, to present, symbiotics of dr. (b)(6), 2 capsules at night, to present, and vitamin c, 1000 mg in 2 divided doses. On (b)(6) 2020, 13 days after the treatment with radiesse®, the patient experienced edema with a feeling of bursting (as reported), in the lower third of the face and in the nasolabial fat packs where she experienced the accumulation of product. On the same day, the patient also experienced a questionable granuloma in the nasolabial packs and an inflammation in the temporal area, nasolabial packs and buccal area. On (b)(6) 2020, as corrective treatment the patient received aerius, 1 tablet at night, to present, an intramuscular injection of 8 mg of dexamethasone (reported as no. 2), until (b)(6) 2020, trental, 100 mg 3 times a day, to present, lymphomyosot, 25 drops 3 times a day, to present, panangin, 2 tablets per day, to present and flebodia, 600 mg in the morning, to present. On (b)(6) 2020, as corrective treatment the patient received intravenous injections of 500 mg of heptral (reported as no. 5), until (b)(6) 2020, and nimesil (reported as no. 10), 2 packages per day, to present. As reported, on (b)(6) 2020, the edema was stopped by dexamethasone, after 3 days. On (b)(6)2020, as corrective treatment the patient received wobenzym, 3 tablets 3 times a day, to present and fluconazole 150 mg for 7 days, due to the exacerbation of vaginal candidiasis after dexamethasone. On (b)(6) 2020, as corrective treatment the patient was treated with microcurrents and beloderm ointment (reported as no. 8), 2 times a day (reported as no. 4) and once a day (reported as no. 4), on the area of inflammation. Corrective treatment also included an ultrasound examination of the soft tissue of the face, dioxidine solution, on the area of inflammation (nasolabial packs) and in the area of drug accumulation, a solution of plasma therapy, enriched with platelet mass (reported as no. 5), in microbolus, into the zones of drug accumulation, lymphatic drainage and vitamin d, 2500 units on a continuous basis, at the reference level of vitamin d in the serum. As reported, tenderness persisted while taking nimesil until (b)(6) 2020. The patient was not hospitalized. The outcome of the event questionable granuloma was unknown. The outcome of the event tenderness was deemed resolved due to the provided information. The outcome of the remaining events was reported as not resolved. In the opinion of the reporter, the events were of severe intensity, unknown if permanent and related to radiesse®. Follow-up information was received on (b)(6) 2020: the event verbatim questionable granuloma was changed to questionable granuloma/post-traumatic cysts, and recoded from injection site nodule to injection site cyst. The reporter confirmed that lidocaine was added. The patient tolerated all previous procedures well, according to the rehabilitation period and did not experience any events. The final diagnosis was reported as post-traumatic cysts with granuloma in question. The histological examination of the granuloma was not carried out and was not planned. After the patient experienced the local edema, she received intramuscularly, dexamethasone 8 mg (twice) and used beloderm ointment, introduced by phonophoresis and then she took nemisil (nemisulide 100 mg) once a day. The physician was not sure if the reported tenderness was caused by taking nemisil. As reported, in regard to the pastosity, accumulation of the product and local inflammation, the patient was still the same. The outcome of the event post-traumatic cysts was unknown. The outcome of the remaining events was left unchanged. Follow-up information was received on (b)(6) 2020: the reporter confirmed that the diagnosis was made on ultrasound, where the fluid content in the cyst was determined on the left in the region of the marginal fold. On (b)(6) 2020, the result of the soft tissue ultrasound examination of the face showed that there was a significant edema of the subcutaneous fat of both cheeks with dilated interstitial spaces and the presence of the medicinal product at different stages of biodegradation. Subcutaneous fat layer in the area of the left cheek there were multiple depots of the medicinal product from 0. 23 cm2 to 0. 7 cm2. Subcutaneous fat layer in the area of the right cheek there was a single depot of the medicinal product 1 x 0. 7 cm. Jaw corner on the right side there was an edema zone of the subcutaneous fat and muscle layers with the inclusion of the medicinal product with an area of 3. 6 cm2 (medicinal product migration). Nasolabial zones there were multiple areas of the medicinal product depot. In the temporal region on the left side, there was a package of lymph nodes ranging in size from 3x3. 5 mm to 9x5 mm. All nodes with a smooth outline, oval, without clear differentiation and a slight increase in vascularization. In the temporal region on the right side, there were two structurally similar lymph nodes with dimensions of 8. 5x4. 5 mm and 7. 5x4. 5 mm. On (b)(6) 2020, the result of the soft tissue ultrasound examination of the face showed that on the left side was transition level of the nasolabial zone to the chin there was a 12x5. 5 mm product accumulation with a liquid component (a rim around the product). Subcutaneous fat layer of the labial-marginal fold there were areas of product accumulation from 3x6 mm to 3x5 mm, at different stages of biodegradation. Jaw angle area there were an uneven thickening and compaction of the subcutaneous fat layer, without focal changes. Dimensions of mandibular lymph nodes were 11x4 mm and 6x6 mm. Dimensions of temporal lymph nodes were 7x3 mm, 4. 5x3 mm, 5x2. 6 mm and 3. 2x2. 2 mm. On the right side the result showed that nasolabial fat pack area there was an accumulation of the product without clear contours of 18x8 mm and 9x6 mm dimensions. Nasolabial fold area there was an uneven compaction of the subcutaneous fat. Labial-marginal zone there was an uneven compaction of subcutaneous fat with an accumulation of the product at different stages of biodegradation with 7x4 mm, 8x5 mm and 5x2. 2 mm dimensions. Dimensions of temporal lymph nodes were 9x3. 6 mm, 7x3. 8 mm and 4. 7x3. 3 mm. Dimension of the mandibular lymph node were 14 mm x 7. 5 mm. After the corective treatment with phonophoresisand hydrocortisone ointment, the reporter planned to treat the significant soft tissue trauma with plasma therapy with diprospan in places where the product and cysts accumulated. The reporter confirmed that the both post-traumatic cyst and accumulation of the product in form of conglomerates were present with palpatory tenderness on formations. The pastosity of the face was a consequence of post-traumatic inflammation and the presence of the product in tissues, which exerted a compressive effect on the vessels, thereby causing the inflammatory process. Allergy was in this case excluded. The pathological phenomena was associated with the administration of a large volume of the drug 12 ml and its uneven distribution in the tissues during the administration. In the opinion of the reporter, the events were related to radiesse®. The outcome of the added event was not reported and of the previously reported events was left unchanged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRADIESSE INJECTABLE IMPLANT
Type of DeviceIMPLANT, DERMAL, FOR AESTHETIC USE
Manufacturer (Section D)
MERZ NORTH AMERICA, INC.
4133 courtney street
suite 10
franksville WI 53126
Manufacturer (Section G)
MERZ NORTH AMERICA, INC
4133 courtney street
suite 10
franksville WI 53126
Manufacturer Contact
product safety
6501 six forks rd
raleigh, NC 27615
9195828000
MDR Report Key10945143
MDR Text Key219493680
Report Number3013840437-2020-00120
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
P050052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2021
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 Treatment Data
Date Received: 12/04/2020 Patient Sequence Number: 1
Treatment
ERGOCALCIFEROL; ETOXYDOL; SIDERAL
-
-