BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER: SILVERSOAKER 2.5IN, 100ML, 2ML/HR

    MDR report key: 3113731 · Received May 10, 2013

    Report

    Report Number
    2026095-2013-00090
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 11, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE WILL NOT BE RETURNED FOR AN EVALUATION AND INVESTIGATION. RESULTS: A DEVICE HISTORY REVIEW IS BEING CONDUCTED. CONCLUSIONS: THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    DRUG/DILUENT: MACAINE 0.5%, FILL VOLUME: 2.0 ML, FLOW RATE: 100 ML/HR, PROCEDURE: HERNIA CATHPLACE: UNKNOWN, DATE OF PROCEDURE: ON (B)(6) 2013. IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE EVENING THE PATIENT RETURNED HOME AFTER SURGERY IT SEEMS AS IF HER HUSBAND HAD A STROKE. HE WAS CONFUSED AND COULDN'T REMEMBER ANYTHING, AFTER THE PUMP WAS REMOVED THE PATIENT COULD NOT WALK NOR TALK AND ENDED UP IN THE ER. THE ER PHYSICIAN SAID THAT IT MUST HAVE BEEN A REACTION TO THE MEDICATION THAT WAS IN THE ON-Q PAIN PUMP. THE PATIENT IS STILL HAVING ISSUES WITH VERTIGO AND HIS MEMORY SO HE WANTS TO KNOW WHAT MEDICATION WAS IN THE PUMP TO AVOID GETTING IT IN THE FUTURE. PATIENT WAS ADVISED TO CONTACT HIS SURGEON. PATIENT REPORTED THAT THE SURGEON WAS NOT SURE WHICH MEDICATION WAS USED IN THE PUMP. HE WAS ADVISED TO CALL THE SURGICAL CENTER AND ASK THEM. HE WAS INFORMED THAT WE DO NOT MAKE THE DRUG, ONLY THE PUMP. THE PATIENT DOES NOT HAVE THE PUMP OR ANY OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207639 ON-Q PAINBUSTER: SILVERSOAKER 2.5IN, 100ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC PM012-A 020077486

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O ASPRIN| CLOPDIGROL| PLAVIX| AVODART| PANTOPRAZOLE| RAPAFLO| LOVASTATIN| PROTHANTONAL| TARVEDILOL