BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC SAF/PCA

    MDR report key: 1960233 · Received January 5, 2011

    Report

    Report Number
    2026095-2010-00334
    Event Type
    Other
    Date Received
    January 5, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WITH RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PT'S HUSBAND REPORTED THAT THE BUTTON WAS STUCK DOWN. WIFE IN LOTS OF PAIN. ORANGE INDICATOR AT THE BOTTOM. HOTLINE INSTRUCTED TO TAP BOLUS ON HARD SURFACE. THE BUTTON POPPED BACK UP. WORKED FOR A WHILE, BUT HOTLINE RECEIVED ANOTHER CALL A FEW HOURS LATER SAYING IT WAS STUCK AGAIN. INSTRUCTED TO CLAMP PUMP AND REMOVE PER DOCTOR'S INSTRUCTIONS. PT DID NOT FEEL COMFORTABLE REMOVING PUMP, SO WOULD WAIT UNTIL DOCTOR'S VISIT. SAID THE SAF WOULD BE TURNED TO "0". NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2010. ANP: ASKED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC SAF/PCA ELASTOMERIC PUMP MEB I-FLOW CORP. CB006 ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR