BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTRICULAR BOLT ICP MONITOR KIT W/CRANIAL ACCES

    MDR report key: 2001068 · Received February 14, 2011

    Report

    Report Number
    1722447-2011-00003
    Event Type
    Other
    Date Received
    February 14, 2011
    Report Date
    July 20, 2011
    Manufacturer
    INTEGRA PAIN MANAGEMENT
    Product Code
    GWM
    Removal / Correction Number
    Z-2171-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BOX WAS LABELED AS 110-4HC (COMPLETE VENTRICULAR BOLT PRESSURE MONITORING AND DRAINAGE KIT). HOWEVER, THE COMPONENTS INSIDE THE BOX WERE FOR THE PRODUCT 110-4HMC (COMPLETE MICRO VENTRICULAR BOLT PRESSURE MONITORING AND DRAINAGE KIT). ADDITIONAL INFO HAS BEEN REQUESTED, HOWEVER, NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRICULAR BOLT ICP MONITOR KIT W/CRANIAL ACCES NA GWM INTEGRA PAIN MANAGEMENT 170314

    Patients

    Seq Age Sex Outcome Treatment
    1