BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOC, 400ML, 2-14 ML/HR SAF

    MDR report key: 2520447 · Received April 4, 2012

    Report

    Report Number
    2026095-2012-00050
    Event Type
    Injury
    Date Received
    April 4, 2012
    Date of Event
    March 17, 2012
    Report Date
    March 17, 2012
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE. FILL VOLUME: 550 ML. FLOW RATE: UNK. PROCEDURE: ROTATOR CUFF REPAIR. CATHPLACE: UNK. PT STATES A POUNDING IN EARS AND WAS AWAKENED TWICE. DRYNESS IN MOUTH AND METAL TASTE. PT DENIES NUMBNESS OR TINGLING TO TOES OR FACE, CONFUSION, DIZZINESS, ETC. STATES PAIN IS WELL CONTROLLED AND HAS BEEN USING THE SAF FEATURE AT 12, 8, AND NOW 6ML/HR. PT WAS ADVISED TO CLAMP OFF PUMP AND CALL HER PHYSICIAN. F/U WITH PT 30 MINUTES LATER. PHYSICIAN INSTRUCTIONS WERE TO LEAVE PUMP OFF AND REMOVE IT. PT WAS IN THE PROCESS OF REMOVING CATHETER. PT WAS ADVISED IF SYMPTOMS CONTINUED TO CONTACT HER DOCTOR AND TAKE MEDICATION FOR PAIN AS DIRECTED. PT WAS INSTRUCTED TO SAVE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC, 400ML, 2-14 ML/HR SAF ELASTOMERIC PUMP MEB I-FLOW CORPORATION 101347200 0200307187

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other