BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11092113 · Received December 29, 2020

    Report

    Report Number
    3012307300-2020-12836
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 29, 2020
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT GRIGGS WAS IN USE DURING A PROCEDURE. THE PATIENT WAS REPORTED TO HAVE A CEREBRAL HEMORRHAGE, AND HIS CONDITION REQUIRES A MINIMALLY INVASIVE PERCUTANEOUS TRACHEOTOMY. THE DOCTOR SUDDENLY BROKE THE FORCEPS WHEN HE USED THE FORCEPS TO EXPAND THE SKIN, AND IMMEDIATELY REPLACED WITH A NEW PRODUCT, WHICH DID NOT CAUSE ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550510 PORTEX TRACHEOSTOMY BTL 8.0MM

    Patients

    Seq Age Sex Outcome Treatment
    1