BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN REVOLVE

    MDR report key: 19038211 · Received April 3, 2024

    Report

    Report Number
    1000306051-2024-00081
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Report Date
    April 3, 2024
    Manufacturer
    LIFECELL
    Product Code
    QKL
    PMA / PMN Number
    BK220695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED TO FDA IN AN ABUNDANCE OF CAUTION AS A REPORTABLE MALFUNCTION DUE TO THE "STRANGE OBJECT" FOUND IN THE ASPIRATED FAT. A RELATIONSHIP BETWEEN THE REVOLVE AND THIS EVENT COULD NOT BE DETERMINED WITHOUT FURTHER ANALYSIS OF THE SUSPECT DEVICE. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED VIA DISTRIBUTOR THAT A FOREIGN OBJECT WAS FOUND IN THE SYRINGE OF ASPIRATED FAT. THE REVOLVE DEVICE RETURN STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689707 UNKNOWN REVOLVE LIPOASPIRATE WASHING SYSTEM FOR AESTHETIC BODY CONTOURING QKL LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown