BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 336826 · Received June 7, 2001

    Report

    Report Number
    MW1022129
    Event Type
    Injury
    Date Received
    June 7, 2001
    Date of Event
    March 28, 2001
    Report Date
    May 31, 2001
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS THE ON 1 PUMP ATTACHED AT THE END OF SURGERY FOR BUNIONECTOMY. THE CATHETER IS PLACED UNDER THE SKIN AND IS ATTACHED TO THE INFUSION DEVICE. THIS DEVICE HOLDS 270 ML OF ANESTHESIA. PLAIN MARCAINE WAS USED. THE DEVICE AUTOMATICALLY DELIVERS 2CC Q HR CONTINUALLY UNTIL THE PUMP IS EMPTY. THE CONTINUOUS INFUSION OF THIS FLUID OVER TIME CAUSED SWELLING, PAIN, BLISTERING OF SKIN FROM CELL DEATH. ISCHEMIC NECROSIS OF BLISTER WITH FULL SKIN SLOWER DOWN TO BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26511 * ON Q PUMP - INFUSES LOCAL ANESTHESIA MEB I-FLOW * *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R