ELLACOR SYSTEM WITH MICRO-CORING TECHNOLOGY
Received Nov 6, 2023 · Event occurred Sep 18, 2023
Report 3020704367-2023-00021 · MDR key 18077341
Device
Generic name
Micro-coring Technology
Manufacturer
Cytrellis Biosystems, IncProduct problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Granuloma
- Granuloma
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE NURSE WHO RECEIVED TREATMENT DEVELOPED GRANULOMA ON JAWLINE 2-3 WEEKS AFTER ELLACOR TREATMENT. SHE HAD FILLER 4-5 MONTHS PRIOR AND OFFICE REALIZES PROTOCOL TO WAIT 6 MONTHS. THEY DID A CULTURE AND IT CAME BACK CORYNEBACTERIUM. PATIENT TREATED WITH ANTIBIOTICS.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE NURSE WHO RECEIVED TREATMENT DEVELOPED GRANULOMA ON JAWLINE 2-3 WEEKS AFTER ELLACOR TREATMENT. SHE HAD FILLER 4-5 MONTHS PRIOR AND OFFICE REALIZES PROTOCOL TO WAIT 6 MONTHS. THEY DID A CULTURE AND IT CAME BACK CORYNEBACTERIUM. DURING INVESTIGATION, THE PROVIDER STATED THAT THE PATIENT "IS IMPROVING". A CULTURE DID GROW CORYNEBACTERIUM. PATIENT COMPLETED ANTIBIOTICS AND GRANULOMA HAS REDUCED IN SIZE. NO PAIN OR OTHER SYMPTOMS REPORTED. PER VICE PRESIDENT, SCIENTIFIC AFFAIRS AND MEDICAL DIRECTOR THE PREVIOUS DERMAL FILLER THAT WAS PLACED LESS THAN 6 MONTHS AGO MAY HAVE CONTRIBUTING FACTOR FOR INFECTION. THERE IS NO PATHOLOGY REPORT DIAGNOSING PATIENT WITH GRANULOMA BUT ONLY A CULTURE REPORT DIAGNOSING CORYNEBACTERIUM.