BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROAIRE PULSE LAVAGE

    MDR report key: 83323 · Received April 15, 1997

    Report

    Report Number
    2020601-1997-00044
    Event Type
    Injury
    Date Received
    April 15, 1997
    Date of Event
    April 8, 1997
    Report Date
    April 15, 1997
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, INC.
    Product Code
    FQH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP, THE NOZZLE OF THE PRODUCT FELL OFF INTO THE FEMUR. THE SURGEON WAS UNABLE TO RETRIEVE THE NOZZLE PRIOR TO COMPLETING HIP REPLACEMENT. THE SURGEON CLOSED THE HIP AND PROCEEDED TO CUT THE FEMUR AT THE DISTAL END AND SUCCESSFULLY REMOVED THE NOZZLE FROM THE FEMUR. NO PERMANENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROAIRE PULSE LAVAGE PULSE LAVAGE HIP TUBE SET FQH MICROAIRE SURGICAL INSTRUMENTS, INC. 4740-061 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention