BEUDAMED
    FDA Adverse Event Injury Summary report: N

    "ON-Q" PUMP

    MDR report key: 537611 · Received June 18, 2004

    Report

    Report Number
    MW1032477
    Event Type
    Injury
    Date Received
    June 18, 2004
    Date of Event
    May 10, 2004
    Report Date
    June 18, 2004
    Manufacturer
    I FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD UNEVENTFUL REPEAT CESAREAN USING "ON-Q" PUMP FOR PAIN RELIEF. REQUIRED REOPERATION DUE TO OOZING FROM SUBCUTANEOUS TISSUE PRESUMED SUBSEQUENTLY DUE TO "ON-Q" PUMP SINCE NO BLEEDING SOURCE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "ON-Q" PUMP INFUSION PUMP MEB I FLOW * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention