BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRIP-LOK

    MDR report key: 7906666 · Received September 25, 2018

    Report

    Report Number
    2182318-2018-00008
    Event Type
    Injury
    Date Received
    September 25, 2018
    Date of Event
    September 9, 2016
    Report Date
    September 13, 2018
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: SINCE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, THE REPORTED ISSUE COULD NOT BE CONFIRMED. THIS REPORT IS BEING SUBMITTED SOLELY ON THE REPORTED ISSUE. IF THE LINE BECOMES STUCK TO THE DEVICE WHEN ATTEMPTING TO REPLACE THE DEVICE, UNINTENDED LINE REMOVAL OR INTERRUPTION OF PATIENT TREATMENT IS LIKELY. THIS REPORT IS BEING SUBMITTED AS A RESULT OF A REMEDIATION CAPA TO REASSESS PRODUCT RISKS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE DEVICE IS REMOVED FROM THE LINES, THE ADHESIVE SEPARATES FROM THE TOP VELCRO TAB AND THE LINE IS STUCK IN THE DEVICE. THE ISSUE WAS REPORTED ON (B)(4) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748264 GRIP-LOK GRIP-LOK MEDIUM STERILE KMK TIDI PRODUCTS LLC 3300M 23249833

    Patients

    Seq Age Sex Outcome Treatment
    1 Other