BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 PACK REVOLVE FAT PROCESSING SYSTEM

    MDR report key: 23854501 · Received December 19, 2025

    Report

    Report Number
    1000306051-2025-00123
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    September 22, 2025
    Report Date
    December 19, 2025
    Manufacturer
    LIFECELL
    Product Code
    QKL
    UDI-DI
    00818410012205
    PMA / PMN Number
    BK220695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED AS IT IS AN UNANTICIPATED MALFUNCTION OF THE DEVICE THAT AS PER THE SURGEON IN THIS CASE RESULTED IN A NEGATIVE IMPACT ON THE PATIENT. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED THAT DURING DOING LIPO FILLING, FAT ESCAPED TO THE SUCTION BOTTLE AND WE HAD TO HARVEST AGAIN TO PROCESS TO FILL THE AREA. AFTER THE PROCEDURE, THEY CUT THE SUCTION LINER AND SEPARATED THE FAT TO TAKE PICTURES. THE MESH DID LOOK INTACT. REVOLVE KIT, REF- RV0001WW, LOT- 1279978. NO OTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED LATER ADVISING THAT ONLY ONE HARVEST WAS PERFORMED AND THERE WAS AN IMPACT ON THE PATIENT BECAUSE THE PATIENT WAS SLIM AND HAS NOT MUCH FAT LEFT TO TAKE OUT, FIRST HARVEST WENT TO THE DRAIN. A NEW KIT WAS OPENED, THE FAT WAS TAKEN AGAIN AND MINIMAL FILLING WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564862 1 PACK REVOLVE FAT PROCESSING SYSTEM LIPOASPIRATE PROCESSING SYSTEM FOR AESTHETIC BODY CONTOURING QKL LIFECELL 1279978 00818410012205

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown