BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFLO ON Q PAIN PUMP

    MDR report key: 1284906 · Received January 8, 2009

    Report

    Report Number
    MW5009565
    Event Type
    Injury
    Date Received
    January 8, 2009
    Date of Event
    August 8, 2006
    Report Date
    January 8, 2009
    Manufacturer
    IFLO
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BREAST AUGMENTATION DONE AT HEALTH CENTER. DR USED THE ON Q PAIN PUMP. DURING PLACEMENT OF THE RIGHT CATHETER, HE CAUSED A RIGHT IATROGENIC PNEUMOTHORAX, AND WHILE REMOVING THE LEFT SIDE OF THE CATHETER, HE PULLED SO HARD, IT BROKE. HE NEVER FOUND OUT WHERE THE CATHETER IS LOCATED, "HE SAID JUST LEAVE IT WHERE IT IS. "I HAVE TRIED ON MY OWN TO HAVE IT LOCATED, X-RAYS, ULTRA SOUNDS, MRI AND A MAMMOGRAM. IT IS NOT SHOWING UP. I WANT TO KNOW IF IT IS IN A SAFE PLACE OR WHAT IF IT MIGRATED. I AM SCARED TO DEATH AND EXPERIENCE PAIN DAILY. ROUTE: SQ. DATES OF USE: 2006. DIAGNOSIS OR REASON FOR USE: PAIN CONTROL AFTER BREAST AUGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IFLO ON Q PAIN PUMP ONQ PAIN PUMP MEB IFLO

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O| S