BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I FLOW

    MDR report key: 336832 · Received June 7, 2001

    Report

    Report Number
    MW1022130
    Event Type
    Injury
    Date Received
    June 7, 2001
    Report Date
    May 31, 2001
    Manufacturer
    I FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT FOOT SURGERY AT HOSP 3/01. THE ON Q PUMP WAS USED TO KEEP THE SURGICAL SITE NUMB, AFTER SURGERY. THE ON Q PUMP HOLDS 270 ML OF LOCAL ANESTHESIA (.25% PLAINE MARCAINE). THE FOOT BECAME SWOLLEN, PAINFUL, THE CATHETER LINE SITES BECAME INFECTED THE FOOT DEVELOPED A TENSE BLISTER WHICH DEVELOPED INTO A FULL THICKNESS SKIN SLOUGH. BLISTERY EDEMA, CELLUTIS, NECROSIS OF TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26368 I FLOW ON Q PUMP MEB I FLOW * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R JUST THE ON Q PUMP.| 1) NO OTHER MEDICAL PRODUCTS OR DEVICE WERE USED,