BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYPROPYLENE

    MDR report key: 8970341 · Received September 6, 2019

    Report

    Report Number
    3012164473-2019-00021
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Report Date
    September 6, 2019
    Manufacturer
    CP MEDICAL
    Product Code
    GAW
    UDI-DI
    10889950001919
    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 SIZE 4/0 POLYPROPYLENE SUTURE BREAKING DURING SURGERY, AFTER IMPLANT AND GRAFTING. (LOT# 180612-67) THERE WAS PATIENT INVOLVEMENT WITH A HEALTHY MIDDLE-AGED MALE BUT NO INDICATION OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764744 POLYPROPYLENE POLYPROPYLENE NONABSORBABLE SYNTHETIC SUTURE GAW CP MEDICAL 8683P-HUF 180612-67 10889950001919

    Patients

    Seq Age Sex Outcome Treatment
    1