BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3201588 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00074
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    January 5, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003. PRODUCT TYPE: CATHETER. (B)(4). DRUG RUNNING UNDER THE SKIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ¿DRUG RUNNING UNDER HER SKIN.¿ IT WAS NOTED THAT IF THE HEALTH CARE PROFESSIONAL HADN¿T CAUGHT IT, THE PATIENT COULD HAVE ENDED UP IN A COMA OR DIED. IT WAS ALSO REPORTED THAT THE BATTERY WAS ¿RUNNING DEAD¿ AND THE PUMP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303220 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1