BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAIN PUMP TUBING

    MDR report key: 8861639 · Received August 5, 2019

    Report

    Report Number
    1220246-2019-01229
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    June 12, 2019
    Report Date
    August 5, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    UDI-DI
    00888867118010
    PMA / PMN Number
    K083707
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE DISPOSITION IS UNKNOWN. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WA REPORTED VIA FDA MEDWATCH LETTER (MW5087791) THAT THE FOLLOWING INCIDENT HAS BEEN REPORTED: THE SENSOR IN FLUID CHAMBER OF THE ARTHROSCOPY PUMP TUBING NOTED TO BE "FLAT" IN APPEARANCE. DID NOT REGULATE THE INFLOW OF IRRIGATION FLUID TO LEFT KNEE, CAUSING FLUID SUBLIGATION TO SUBCUTANEOUS TISSUE LEFT KNEE TO GROIN. PROCEDURE: ARTHROSCOPY LEFT KNEE. THE MEDWATCH LETTER DID NOT CONTAIN ANY REPORTER OR FACILITY NAME OR CONTACT INFORMATION. THEREFORE NO FOLLOW UP CAN BE PERFORMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655358 MAIN PUMP TUBING ARTHROSCOPE HRX ARTHREX, INC. MAIN PUMP TUBING 32454024 00888867118010

    Patients

    Seq Age Sex Outcome Treatment
    1 Other