BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON Q PUMP

    MDR report key: 337527 · Received June 13, 2001

    Report

    Report Number
    MW1022160
    Event Type
    Injury
    Date Received
    June 13, 2001
    Date of Event
    December 15, 2000
    Report Date
    May 31, 2001
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ENDOSCOPIC PLANTAR FASCIOTOMY. POSTOP ON Q CATHETER WAS PLACED. IT WAS CEMENTED TO ON Q PUMP WITH 270 ML PLAIN MARCAINE. THE AREA WHERE THE CATHETER PLACES MEDICINE IN TISSUE DEVELOPED A BLISTER AND CONTINUED TO BECOME A FULL THICKNESS SLOUGH OF SKIN ON PLANTAR HEEL. NO OTHER MEDICAL PRODUCT WAS USED. THERAPY TO TREAT ULCER FOR MONTHS AFTER. WOUND IS ABOUT 50% HEALED AT THIS POINT. PT UNDERWENT AN ENDOSCOPIC PLANTAR FASCIOTOMY. DR USUALLY DOES NOT USE THE ON Q PUMP FOR THESE CASES. THIS ONE INSTANCE IT WAS USED, THIS WAS THE RESULT. THE WOUND STARTED AS A SUPERFICIAL LARGE BLISTER, FILLED WITH FLUID (CLEAR) - SIGN OF TISSUE DEATH, CONTINUED TO PROGRESS RAPIDLY TO ISCHEMIC, NECROTIC AREA, REQUIRING ONGOING WOUND CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27115 ON Q PUMP INFUSED LOCAL ANESTHESIA MEB I-FLOW ON Q PUMP *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention