BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDERI STRETTA CATHETER

    MDR report key: 6456594 · Received April 4, 2017

    Report

    Report Number
    3007729452-2017-00002
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Report Date
    April 3, 2017
    Manufacturer
    MEDERI THERAPEUTICS INC
    Product Code
    GEI
    UDI-DI
    00856219002294
    PMA / PMN Number
    K000245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    A COMPANY FIELD REPRESENTATIVE NOTED A PRODUCT PROBLEM AND IT WAS CONFIRMED BY THE COMPANY THROUGH INSPECTION OF INTERNAL INVENTORY THAT THE PROBLEM COULD RESULT IN A BREACH IN THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240528 MEDERI STRETTA CATHETER ELECTROSURGICAL DEVICE GEI MEDERI THERAPEUTICS INC 175-5580 299ST-16 00856219002294

    Patients

    Seq Age Sex Outcome Treatment
    1