BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYPROPYLENE

    MDR report key: 9566614 · Received January 8, 2020

    Report

    Report Number
    3012164473-2020-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    CP MEDICAL
    Product Code
    GAW
    UDI-DI
    10889950001865
    PMA / PMN Number
    K001185
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SIZE 6/0 POLYPROPYLENE SUTURE BROKE DURING A PROCEDURE WITHIN A PATIENT'S MOUTH. (LOT# 180404-56) THERE WAS PATIENT INVOLVEMENT BUT NO INDICTATION OF AN ADVERSE EVENT. THE PROCEDURE WASNT DELAYED GREATER THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30101 POLYPROPYLENE POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE GAW CP MEDICAL 1011P-HUF 180404-56 10889950001865

    Patients

    Seq Age Sex Outcome Treatment
    1