BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTLIPO,600UM FIBER,SINGLE,STERILE

    MDR report key: 13257937 · Received January 14, 2022

    Report

    Report Number
    1222993-2022-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 15, 2021
    Report Date
    January 14, 2022
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    PMA / PMN Number
    K091537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. ADDITIONAL INFORMATION WAS REQUESTED, BUT NONE WAS PROVIDED DESPITE MULTIPLE REQUESTS TO THE PROVIDER. A DEVICE EVALUATION COULD NOT BE PERFORMED SINCE SITE HAS NOT RESPONDING TO MULTIPLE REQUESTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SECOND FIBER SNAPPED DURING TREATMENT AND BURNED THE PROVIDER. FIRST FIBER WAS REPORTED IN MDR# 1222993-2022-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808709 SMARTLIPO,600UM FIBER,SINGLE,STERILE SMARTLIPO,600UM FIBER,SINGLE,STERILE GEX CYNOSURE LLC 109935-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown