BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON Q PUMP

    MDR report key: 1628678 · Received March 5, 2010

    Report

    Report Number
    MW5015046
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    February 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    I FLOW
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ON ON Q PUMP POST OPERATIVELY AND WHILE PHYSICIAN WAS ATTEMPTING TO REMOVE IT ON (B) (6) 2010 CATHETER BROKE OFF. PT WAS RETURNED TO SURGERY FOR REMOVAL OF THE RETAINED CATHETER. AFTER INVESTIGATIONS AND REVIEW, IT WAS DETERMINED POSSIBLY THE CATHETER WAS SEWN IN WHILE SUTURING DURING SURGERY. DIAGNOSIS OR REASON FOR USE: RIGHT OVARIAN CYST. ON Q PUMP - USED FOR PAIN CONTROL FROM (B) (6) 2010 TO (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON Q PUMP PAIN PUMP MEB I FLOW 9A2969
    2 ON Q SILVER SOAKER NONE MEB I FLOW 9A3569

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization