BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURITY

    MDR report key: 5999426 · Received October 5, 2016

    Report

    Report Number
    5999426
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 12, 2016
    Manufacturer
    COVIDIEN LLC
    Product Code
    FQM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A WOUND CARE NURSE NOTICED SOME FOREIGN MATTER INSIDE THE PACKAGING OF 4" CURITY STRETCH BANDAGE BEFORE IT WAS OPENED. WOUND CARE FORWARDED THE UNUSED BANDAGE TO MATERIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650874 CURITY BANDAGE, ELASTIC FQM COVIDIEN LLC 2236 16F118562

    Patients

    Seq Age Sex Outcome Treatment
    1