BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2842768 · Received November 21, 2012

    Report

    Report Number
    6000030-2012-00209
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, LOT# L48812, IMPLANTED: 1997-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP "IRRITATES AND BOTHERS HER ESPECIALLY WHEN SHE ROLLS TO HER LEFT SIDE AND BECAUSE THE PUMP IS LOCATED AT HER WAIST LINE AND HER PANTS RUB ON THE SKIN OVER HER PUMP". THE PUMP HAS BEEN TURNED OFF FOR 4-5 YEARS. THE PATIENT'S STATUS WAS FAIR. THE DRUG BEING USED IN THE PUMP WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention