BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PUMP

    MDR report key: 1837336 · Received September 14, 2010

    Report

    Report Number
    2026095-2010-00158
    Event Type
    Other
    Date Received
    September 14, 2010
    Date of Event
    January 18, 2010
    Report Date
    September 8, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE RECEIVED FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL PRODUCT NUMBER, PRODUCT, OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THE LOT AND DEVICE HISTORY RECORDS CANNOT BE REVIEWED WITHOUT A LOT NUMBER. NO INFORMATION PROVIDED DURING THE INVESTIGATION INDICATED THAT THE DEVICE HAD MALFUNCTIONED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE WE WILL REOPEN THIS COMPLAINT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED HYPERBILIRUBINEMIA (JAUNDICE), SO PUMP WAS DISCONTINUED. PHYSICIAN STATED THAT THE SYMPTOMS QUICKLY RESOLVED AFTER REMOVAL OF THE ON-Q.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other