BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q, 400ML, 2-14ML/HR SELECT-A-FLOW, PUMP

    MDR report key: 2220324 · Received August 16, 2011

    Report

    Report Number
    2026095-2011-00220
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE RECEIVED FOR EVALUATION AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RESULTS: WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: UNKNOWN AND FLOW RATE: 9ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. PATIENT REPORTED THAT SHE SUFFERED NUMBNESS OF THE TONGUE APPROXIMATELY 12 HOURS AFTER SURGERY. PATIENT WAS AT HOME WHEN SYMPTOMS OCCURRED. DOCTOR ADVISED THE PATIENT TO LOWER THE RATE OF THE PUMP AND HER SYMPTOMS WENT AWAY. THE NEXT DAY, PATIENT HAD NO SIGNS OF TOXICITY AND THE PUMP WAS INFUSING AT 10ML/HR. PATIENT IS STABLE AND STARTING THERAPY SOON. DATE OF EVENT: (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q, 400ML, 2-14ML/HR SELECT-A-FLOW, PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. P400X2-14 142642

    Patients

    Seq Age Sex Outcome Treatment
    1 Other