EVAMATIC

Additional Manufacturer Narrative

FOLLOWING TESTS CARRIED OUT BY THE HEALTHCARE FACILITY IN QUESTION, THE DEVICE, INCLUDING THE SECURITY SYSTEM, WAS FOUND TO BE FUNCTIONING AS EXPECTED. THE DEVICE UNDERWENT FURTHER FUNCTIONALITY TESTING BY EUROMI, CONFIRMING THAT THERE WAS NO DEVICE MALFUNCTION. AFTERWARDS, THE DEVICE WAS RETURNED TO THE HOSPITAL (AT THE REQUEST OF THE HOSPITAL PERSONNEL). AS A RESULT, THE INCIDENT WAS LINKED TO THE SURGICAL MANIPULATION ITSELF, AND NOT A DEVICE MALFUNCTION. PERSONNEL INVOLVED WERE RE-TRAINED ON THE USE OF THE DEVICE BY A COMPANY REPRESENTATIVE. REPORTED INITIALLY SUBMITTED BY MANUFACTURER IN SEPTEMBER 2022 (DELAY DUE TO COMPANY PERSONNEL TURNOVER). RE-SUBMITTED IN CORRECT FORMAT VIA THE ESG PORTAL IN JUNE 2023 FOLLOWING FDA EMAIL EXPLANATION.

Description of Event or Problem

PATIENT UNDERWENT A MASTOPEXY AND ABDOMINAL-LUMBAR LIPOSUCTION ON (B)(6). ON DAY 1, POST-SURGERY, INTENSE UNRELIEVED ABDOMINAL PAIN APPEARED, PROMPTING A CT SCAN WHICH REVEALED A BOWEL PERFORATION.