BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS2-SP

    MDR report key: 3754157 · Received January 29, 2014

    Report

    Report Number
    2938001-2014-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    December 11, 2013
    Report Date
    January 29, 2014
    Manufacturer
    MEDICAL DEVICE RESOURCE CORP.
    Product Code
    MUU
    PMA / PMN Number
    K081593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER FILED A MDR #(B)(4). CUSTOMER INCORRECTLY REPORTED THAT THE DEVICE LS2-SP ASPIRATOR (MUU) (S/N: (B)(4)) MALFUNCTIONED. IN THE CUSTOMER'S MDR REPORT (#(B)(4)) THE DEVICE LS7020 CANISTER, WHICH CAN BE USED AS ACCESSORY WITH THE LS2-SP IMPLODED; THE LS2-SP DID NOT MALFUNCTION AND WAS FOUND TO BE IN FULL WORKING ORDER. HENCE THE DEVICE WAS NEVER SENT BACK TO MDRC FOR EVAL AND NO TESTS WERE CARRIED OUT BY MDRC.

    Description of Event or Problem · 1

    MEDICAL DEVICE RESOURCE CORPORATION (MDRC) RECEIVED COPY OF MDR (REPORT # (B)(4)) THAT REASONABLY SUGGESTS DISPOSABLE CANISTER 'LS7020' MAY HAVE CAUSED OR CONTRIBUTED TO A REPORTABLE EVENT. THE REPORT DESCRIBES THAT 'LS7020' CANISTER ON POWER ASPIRATOR RUPTURED, SPILLING ITS CONTENTS (BODY FLUIDS AND FAT)", "NO STAFF MEMBERS WERE EXPOSED TO BLOOD/BODY FLUID OR HARMED". IN THE CUSTOMER'S MDR REPORT, THE ASPIRATOR LS2-SP (S/N: (B)(4)) DID NOT MALFUNCTION AND WAS FOUND TO BE IN FULL WORKING ORDER. THE BROKEN CANISTER WAS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62644 LS2-SP SYSTEM SUCTION LIPOPLASTY MUU MEDICAL DEVICE RESOURCE CORP. LS2-SP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other