BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT

    MDR report key: 72544 · Received February 27, 1997

    Report

    Report Number
    72544
    Event Type
    Malfunction
    Date Received
    February 27, 1997
    Date of Event
    January 2, 1997
    Report Date
    January 17, 1997
    Manufacturer
    CAMINO NEURO CARE, INC. SABA MED GROUP, L.P.
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REMOVED ICP CATHETER ON 1/2/97. UPON SKULL FILM X-RAY DONE ON 1/7/97 WAS DISCOVERED SUSPECTED FRACTURED TIP OF ICP CATHETER REMAINING ON RIGHT SIDE. PT RETURNED TO SURGERY FOR EVACUATION OF HEMATOMA AND INCIDENTAL REMOVAL OF FRACTURED CATHETER ON 1/7/97. INJURY TO PT, IF ANY, UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT Implant PRESSURE MONITORING KIT GWM CAMINO NEURO CARE, INC. SABA MED GROUP, L.P. 110-4HM *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other CRANIAL ACCESS KIT (CAMINO NEUROCARE)