BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 582537 · Received March 15, 2005

    Report

    Report Number
    2026095-2005-00017
    Event Type
    Other
    Date Received
    March 15, 2005
    Date of Event
    February 16, 2005
    Report Date
    February 16, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT'S SPOUSE CONTACTED CLINICAL HOTLINE AT 16:30 HOURS (APPROXIMATELY 48 HOURS FOLLOWING BILATERAL BERNIA REPAIR PROCEDURE). AFTER USING BATHROOM, PATIENT NOTICED THAT THEIR LIP WAS SWOLLEN. SYMPTOMS APPEARED SUDDENLY. PATIENT DENIED DIFFICULTY BREATHING OR SWALLOWING. HOTLINE RN ADVISED PATIENT TO CLOSE TUBING CLAMP ON INFUSION PUMP (ADMINISTERING BUPIVACAINE 0.5%) AND IMMEDIATELY CONTACT THEIR DOCTOR. HOTLINE RN ALSO EMPHASIZED THAT IF PATIENT EXPERIENCED ANY DIFFICULTIES BREATHING OR SWALLOWING, THEY NEEDED TO GO TO THE EMERGENCY ROOM AT ONCE. 17:30 HOURS: HOTLINE RN CALLED PATIENT TO FOLLOW-UP AND LEARNED THAT PATIENT HAD ALREADY GONE TO ER DUE TO SWELLING HAVING WORSENED. THE NEXT DAY, HOTLINE RN SPOKE WITH PATIENT WHO INFORMED HERE THAT THEY HAD GONE TO THE EMERGENCY ROOM BECAUSE THE SWELLING HAD PROGRESSED TO THEIR FACE AND CHIN. PATIENT WAS GIVEN MEDICATION IN THE MERGENCY ROOM AND SWELLING WAS ALMOST GONE AT THAT POINT. PUMP WAS REMOVED FROM PATIENT WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INFUSION PUMP MEB I-FLOW CORP. PM015 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other