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


  • 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

Catalog Number 8071M5K1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cyst(s) (1800)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda, as the event sebaceous cyst (pt: injection site cyst) was deemed to meet serious criteria as surgical treatment was deemed necessary to prevent permanent damage. The device history record of radiesse injectable implant could not be reviewed as the lot number was not reported.
Event Description
This mdr is related to mdr 3013840437-2021-00197 and 3013840437-2021-00198 referring to the same patient. This spontaneous report was received from an (b)(6) physician and concerns a (b)(6) female patient (ambiguously reported as (b)(6)). She was injected with radiesse®, on (b)(6) 2018. The patient was concomitantly injected with bocouture®, into the frontal zone and left cheekbone, on (b)(6) 2018. As reported, according to the physician, the injection site of bocouture® was the frontal zone, while on the legal report it was indicated as the left cheekbone. The patient was injected with bocouture® and radiesse®, over the past 4 years, further described as (b)(6) 2017 and (b)(6) 2018, always with excellent results. In (b)(6) 2019, more than 13 months after the radiesse® injection, the patient experienced swelling on the face, only on one side on the cheekbone, as if she was stung by a bug (insect bite). Since then, the situation worsened with an infection that spread all over the cheek. The reporting physician denied that there was a link to his treatments. Other colleagues also considered the event as linked to different causes. Another physician that was seeing the patient for the second time, said that it was linked to the treatment with radiesse®. On the official medical document, the reported diagnosis was a severe phlogosis on the left side of the cheekbone, with persistent neuralgia radiating from the cheekbone to the eye and left temporal side of face, after the aesthetic treatment. The patient also showed a deformity of the face due to the persistent swelling and redness of the cheekbone, and anxious-depressive neurosis. As reported, during the 4 years, the patient sought the opinion of several different specialists, receiving different corrective treatments including antibiotics and cortisone. The reporting physician had documents from medical experts, that also explained the history of the events, including information on visits and exams taken by the patient. The outcome of the events was reported as not resolved. Follow-up information was received on 23-sep-2021: the follow-up information was received from another physician. The event infection was deleted. The event sebaceous cyst was added. The event term neuralgia was amended to trigemnial neuralgia, and the coding was changed from neuralgia to trigemnial neuralgia. The linking sentence was corrected and additional cases were added. The patients height (176 cm) and weight ((b)(6)) were provided. The patient underwent her first aesthetic treatment with radiesse and bocouture, on the left cheekbone area, on (b)(6) 2017. As reported, in the cosmetic practice, when they were injected together, it was known to cause exostosis as a complication. Further following injection sessions were on (b)(6) 2018 and (b)(6) 2018. The patient did not have any pre-existing spontaneous or traumatic pathology with legal medical relevance for the purposes of the verification. She had normal psychophysical development. In (b)(6) 2019, a rather painful lump appeared on the left cheekbone, which progressively increased in volume. A dermatological examination, followed by another physician was performed, and the patient was diagnosed with a sebaceous cyst. The physician cut it, with discharge of pus and blood, and prescribed high doses of antibiotics. After a short time of wellness, the swelling occurred again and the patient accessed the emergency department of a hospital several times, undergoing repeated incisions with prescriptions of analgesics and antibiotics. On (b)(6) 2019, it was diagnosed as chronic phlogosis of the cheekbone area, with the prescription for a subcutaneous ultrasound of the cheekbone area. The patient was scheduled for magnetic resonance of the facial skeleton bones. On (b)(6) 2019, further specialists examination with an infectious disease specialist showed oedema with signs of phlogosis on the left cheekbone that extended to the ipsilateral eye. Bactrim tablets were recommended. In addition, the patient had an ear, nose and throat re-examination plus a blood test control. On (b)(6) 2019, the phlogosis with painful swelling was confirmed around the left cheekbone and orbital area. Later, blood tests carried out on (b)(6) 2019, confirmed leukocytosis and an increase of the c-reactive protein. On (b)(6) 2019, the patient had an ear, nose and throat control with a physician, who drained purulent material from pre-existing incisions. On (b)(6) 2019, the magnetic resonance of the facial skeleton bones confirmed an increase of the soft tissue swelling in the left lower palpebral orbital cheekbone area, with lateral cervical lymphadenopathy of bilateral reactive grade. She was recommended a maxillofacial surgery examination. On (b)(6) 2019, the injecting physician requested culture testing with an antibiogram, on the secretions. On (b)(6) 2019, the following day, it was carried out and was negative for bacteria. On (b)(6) 2019, the injecting physician prescribed an ear, nose and throat control examination. On (b)(6) 2019, medical examination was preformed, with a prescription of antibiotics and cortisone compounds (bassado + deltacortene). On (b)(6) 2020, blood tests pointed out a persistent leucocytosis with decreased c-reactive protein. On (b)(6) 2020, a different physician gave the patient a prescription (as reported). On (b)(6) 2020, the patient was examined by a different physician who diagnosed outcomes of the radiesse and bocouture injections in the cheekbone area, but erroneously mentioned phlogosis and an infection following an insect sting. On (b)(6) 2020, the same physician prescribed antibiotics and painkillers, with medical treatments and cryotherapy in the cheekbone area. On (b)(6) 2020, the physician prescribed tobradex eye drops, boric water compresses and a soft tissue ultrasound. On (b)(6) 2020, on the ultrasound, the left cheekbone area showed hyperechogenic subcutaneous tissue due to fibrosis. On (b)(6) 2020, on further examination at the hospital, the same physician performed aspiration of the phlogosis content, and advised surgery for a fat self-implant, which the patient did not undergo yet. On (b)(6) 2021, on examination, the patient had intense pain in the left cheekbone radiating to the above eye site and to the temporal area. It increased when chewing, as from trigeminal neuralgia, complicating the phlogosis that was lasting for many years, as well as the recurrent positional paroxysmal headache crises, that the patient did not suffer from before the described events. The patient was a normal female adult, in good conditions of muscle tonotrophism and normal weight, with nothing relevant affecting the various organs and systems not concerned by the injuring event in question. On the left cheekbone, there was an erythematous swelling that was painful, especially when pressed and palpated, with the pain extending to the higher and lower eyelids of the left eye and to the left temple. Isocoric and isocyclic pupils had a normal reaction to light stimuli and to accommodation. There were no speech abnormalities and she had good hearing and visual functions. Psychic disposition was with clear anxiety-depression in reaction to the event. It the examining physicians opinion, the outcome of the injection of the drugs for aesthetic purposes, in the left cheekbone, was complicated by severe phlogosis of the area with persistent neuralgia radiating from the cheekbone to the left eye and temporal site. The permanent face deformation was due to the persistent swelling and redness of the cheekbone area. The persistent anxious-depressive neurosis occurred in reaction to the event. The outcome of the events severe phlogosis and neuralgia remained unchanged. The outcome of the event sebaceous cyst was unknown. In the opinion of a physician, the injuries of the patient following the aesthetic treatment produced temporary inability (a total temporary inability of 100 days and a partial temporary inability of 80 days at 50%) and permanent invalidity (a permanent outcome that was not able to be corrected by medical therapies, physiotherapy or surgery causing biological damage to the psychological and physical integrity of the subject, also contemplating the neuropsychological damage in reaction to the event, corresponding to 25/27% of the total). According to the physician the injuring suitability and efficiency of the intervention showed a plausible and convincing causal nexus.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
4133 courtney street
suite 10
franksville WI 53126
Manufacturer (Section G)
4133 courtney street
suite 10
franksville WI 53126
Manufacturer Contact
product safety
6501 six forks rd
raleigh, NC 27615
MDR Report Key12583636
MDR Text Key274982302
Report Number3013840437-2021-00199
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/13/2018
Device Catalogue Number8071M5K1
Device Lot Number100093868
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/13/2016
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: 10/06/2021 Patient Sequence Number: 1