BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARENCHYMAL PRESSIO CATHETER

    MDR report key: 7884451 · Received September 18, 2018

    Report

    Report Number
    3001587388-2018-18366
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    June 21, 2018
    Report Date
    August 30, 2018
    Manufacturer
    SOPHYSA
    Product Code
    GWM
    PMA / PMN Number
    K162108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE ARE RE-SUBMITTING THIS REPORT AS INITIAL PER 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 3001587388-2018-18366 - 1. LOT #: F0267. RESUBMIT AS INITIAL.

    Description of Event or Problem · 0

    DURING ICP CATHETER IMPLANTATION, THE PROBE HAD TO BE REMOVED BECAUSE IT DID NOT HOLD UP. THE CATHETER BROKE AT THE TIP TO THE CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728988 PARENCHYMAL PRESSIO CATHETER ICP PRESSURE MONITORING CATHETER GWM SOPHYSA ICP CATHETER D0267

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention