CYTRELLIS MICRO-CORING SYSTEM

Description of Event or Problem

IT WAS REPORTED TO THE COMPANY THAT THE TRAINED, ATTENDING PHYSICIAN TREATED THE PATIENT WITH THE ELLACOR SYSTEM WITH NO ISSUES DURING THE TREATMENT. PATIENT PRESENTED 30 DAYS POST TREATMENT WITH RESIDUAL REDNESS AND UNEVEN SKIN CLASSIFIED AS PROLONGED HEALING BY THE PHYSICIAN. FIRM BECAME AWARE OF ADDITIONAL INFORMATION AFTER 90 DAYS OF HEALING, RESULTING IN THIS REPORT. PHYSICIAN TO TREAT WITH FRAXEL, UNKNOWN IF CORRECTION WOULD NATURALLY OCCUR OVER TIME.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. NO DEVICE FAILURES WERE FOUND. ADDITIONALLY, THE SYSTEM DHR AND ASSOCIATED BATCH RECORDS WERE REVIEWED AND ALL WERE IN CONFORMANCE TO THEIR SPECIFICATIONS. MULTIPLE FOLLOW-UP CONVERSATIONS WITH THE ATTENDING PHYSICIAN OCCURRED TO OBTAIN ADDITIONAL INFORMATION TO COMPLETE PATIENT IMPACT ASSESSMENT. PRIOR TO TREATMENT PATIENT WAS DOING AN ON-CAMERA INTERVIEW FOR WHICH SHE WAS WEARING HEAVY MAKEUP. THE PHYSICIAN STATED THAT HE HAD A SIGNIFICANT CHALLENGE REMOVING THE MAKEUP. NOT ALL OF THE MAKE-UP MAY HAVE BEEN REMOVED WHICH WOULD BE COUNTER TO THE TREATMENT INSTRUCTIONS DESCRIBED IN THE OPERATOR'S MANUAL. COMPANY CONTINUES TO WORK WITH THE PHYSICIAN. (B)(4). FIRM SETTING UP ESG ACCESS, MDR SUBMISSION DELAYED, FIRST MDR. NOTE: INVESTIGATION WAS PERFORMED AT THE SYSTEM LEVEL. ALL SYSTEM LEVEL COMPONENTS WERE INVESTIGATED. NO CAUSAL RELATIONSHIP COULD BE MADE BETWEEN THE SYSTEM COMPONENTS AND THE ADVERSE EVENT. ALL SYSTEM COMPONENT UDIS WERE PROVIDED.