BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR PRESSIO CATHETER

    MDR report key: 7809183 · Received August 23, 2018

    Report

    Report Number
    3001587388-2018-18253
    Event Type
    Injury
    Date Received
    August 23, 2018
    Date of Event
    May 10, 2018
    Report Date
    July 9, 2018
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE RE-SUBMITTING THIS REPORT AS PER THE FOLLOWING REQUEST BY FDA: IT APPEARS THAT THESE SUPPLEMENT REPORTS COULD BE ACTUAL INITIAL REPORTS THAT MAY HAVE BEEN ERRONEOUSLY SUBMITTED AS FOLLOW-UPS IN ERROR DUE TO CHECKING BOTH INITIAL BOX AND FOLLOW-UP BOX IN SECTION G7 3001587388-2018-18253 - 1 LOT #: F0061 RESUBMIT AS INITIAL.

    Description of Event or Problem · 0

    THE ICP VENTRICULAR CATHETER SHOWED E001 AFTER BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652906 VENTRICULAR PRESSIO CATHETER ICP PRESSURE MONITORING CATHETER GWM SOPHYSA ICP CATHETER F0061

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention