BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH GRIP/UNI GRIP

    MDR report key: 7506132 · Received May 11, 2018

    Report

    Report Number
    7506132
    Event Type
    Malfunction
    Date Received
    May 11, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 7, 2018
    Manufacturer
    BIODERM, INC.
    Product Code
    KMK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CATHETER SECUREMENT DEVICE NEW OUT OF THE PACKAGE IS RIPPING AT THE SEAM AROUND THE TABS. CATH GRIP 51300NS, LOT DO4403.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350935 CATH GRIP/UNI GRIP ACCESSORIES, CATHETER KMK BIODERM, INC. D04403

    Patients

    Seq Age Sex Outcome Treatment
    1