BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1 PACK REVOLVE FAT PROCESSING SYSTEM

    MDR report key: 23688401 · Received December 1, 2025

    Report

    Report Number
    1000306051-2025-00116
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 22, 2025
    Manufacturer
    LIFECELL
    Product Code
    QKL
    UDI-DI
    00818410012205
    PMA / PMN Number
    BK220695
    Adverse Event
    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 SERIOUS INJURY DUE TO THE REPORTED "NON-SEPARATION OF THE FAT" WHICH CAUSED THE "WASTE CANISTERS ARE FILLED WITH FAT THAT WAS SUPPOSED TO BE USED" WHICH REQUIRED FAT HARVESTING FROM A SECOND DONOR SITE. A REVIEW OF THE DEVICE HISTORY RECORD FOR REVOLVE LOT 1295850 HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING. WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE REVOLVE AND THIS EVENT COULD NOT BE DETERMINED. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENT HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: G.3 THIS REPORT IS BEING FILED TO UPDATE THE MANUFACTURER'S AWARE DATE.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VIA DISTRIBUTOR THAT ¿THE ISSUE WAS NON-SEPARATION OF THE FAT AS YOU CAN SEE THE WASTE CANISTERS ARE FILLED WITH FAT THAT WAS SUPPOSED TO BE USED FOR A FAT TRANSFER TO BREAST. ULTIMATELY THIS COULD NOT BE USED AS THE WASTE CANISTERS ARE NOT STERILE. [THE SURGEON] TOOK FAT FROM ANOTHER SITE THAT THANKFULLY THE PATIENT HAD CONSENTED FOR." THE UNIT WAS NOT SAVED, "UNFORTUNATELY, THIS COULD NOT BEEN HOLD IN THE CLINIC DUE TO HEALTH AND SAFETY/INFECTION ISSUE".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VIA DISTRIBUTOR THAT ¿THE ISSUE WAS NONSEPARATION OF THE FAT AS YOU CAN SEE THE WASTE CANISTERS ARE FILLED WITH FAT THAT WAS SUPPOSED TO BE USED FOR A FAT TRANSFER TO BREAST. ULTIMATELY THIS COULD NOT BE USED AS THE WASTE CANISTERS ARE NOT STERILE. [THE SURGEON] TOOK FAT FROM ANOTHER SITE THAT THANKFULLY THE PATIENT HAD CONSENTED FOR." THE UNIT WAS NOT SAVED, "UNFORTUNATELY, THIS COULD NOT BEEN HOLD IN THE CLINIC DUE TO HEALTH AND SAFETY/INFECTION ISSUE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2755119 1 PACK REVOLVE FAT PROCESSING SYSTEM LIPOASPIRATE PROCESSING SYSTEM FOR AESTHETIC BODY CONTOURING QKL LIFECELL 1295850 00818410012205

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention