BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAMATIC

    MDR report key: 17215995 · Received June 28, 2023

    Report

    Report Number
    3007697975-2021-00011
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    May 27, 2021
    Report Date
    June 28, 2023
    Manufacturer
    EUROMI SA
    Product Code
    QPB
    PMA / PMN Number
    K101413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148047 EVAMATIC LIPOSUCTION PNEUMATIC HAND PIECE QPB EUROMI SA EVAMATIC 5

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization