BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GO BLOCK - SF

    MDR report key: 2877143 · Received December 4, 2012

    Report

    Report Number
    MW5028136
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 4, 2012
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS, LLC
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GO BLOCK ¿ SF CONTINUOUS PERIPHERAL NERVE BLOCK PUMP DID NOT DELIVERY THE PROGRAMMED DOSAGE OF MEDICATION. THE PT HAD POOR PAIN CONTROL AS A RESULT OF THE DEVICE FAILURE. DATES OF USE: (B)(6) 2012. REASON FOR USER: PAIN MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GO BLOCK - SF GO BLOCK PAIN PUMP MEB SYMBIOS MEDICAL PRODUCTS, LLC 510646 12-100670-1074-0606

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other +2DISP ID: (B)(4)| SOLUTIONS A BBRAUN COMPANY LOT # 9 9-1432611+0| THE MEDICATION WAS PREPARED BY CAPS DELIVERING