BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 10894897 · Received November 24, 2020

    Report

    Report Number
    3004122598-2020-00009
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    July 1, 2020
    Report Date
    November 24, 2020
    Manufacturer
    PRODUCTOS MEDLINE, S.A. DE C.V.
    Product Code
    OEZ
    UDI-DI
    10888277538832
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED THAT THE DILATOR BROKE OFF IN THE PATIENT. DESPITE MULTIPLE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. NO SAMPLE WAS RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THAT THE DILATOR BROKE OFF IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355155 MEDLINE INDUSTRIES, INC. MICRO PUNCTURE 4FR REG OEZ PRODUCTOS MEDLINE, S.A. DE C.V. DYNJMAST01 UNK 10888277538832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other