BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q SILVER SOAKER

    MDR report key: 2419320 · Received January 11, 2012

    Report

    Report Number
    2026095-2011-00462
    Event Type
    Injury
    Date Received
    January 11, 2012
    Date of Event
    November 29, 2011
    Report Date
    January 11, 2012
    Manufacturer
    I-FLOW CORP., LLC.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE IS NOT AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. I-FLOW PROVIDES "WARNINGS" ON ITS DFU WHICH STATES THE FOLLOWING: REMOVE CATHETER AS SOON AS INFUSION IS COMPLETE TO REDUCE RISK OF INFECTION AND DIFFICULTY REMOVING CATHETER.

    Description of Event or Problem · 1

    DRUG/DILUENT: BUPIVACAINE 0.5%. FILL VOLUME: 400 ML. FLOW RATE: 4 ML/HR. PROCEDURE: BILATERAL REDUCTION MAMMOPLASTY. CATHPLACE: SUBQ- TUNNELED, LEFT RIGHT UPPER ABDOMEN. DR. (B)(6) REPORTED PAIN AND REDNESS ON PATIENT RESULTING IN CELLULITIS. PATIENT WAS TREATED WITH ANTIBIOTICS AND CELLULITIS WAS REPORTED TO BE RESOLVING. THE PUMP WAS FILLED IN THE PHARMACY. THE INFUSION BEGAN ON (B)(6) 2011 AND ENDED IN (B)(6) 2011. THE PUMP WAS EMPTY AT THE TIME OF DISCONNECT FOR AT LEAST 24 HOURS BUT NOT MORE THAN 48 HOURS. (B)(4), SILVER SOAKER. DATE OF EVENT: (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVER SOAKER ELASTOMERIC PUMP MEB I-FLOW CORP., LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other