BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCA 9F COMPLETE SET

    MDR report key: 8460172 · Received March 28, 2019

    Report

    Report Number
    1216677-2019-00140
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 25, 2019
    Report Date
    March 28, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    BZD
    PMA / PMN Number
    K911780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "OUR BABIES, WHETHER TINY OR BIG, ARE USUALLY COVERED IN SOME FORM OF " BIRTH PROCESS." MAY BE BLOOD OR A WHITE, CHEESE LIKE COATING. THE FP HATS ARE NOT EASY TO GET ON A DRY BABY AT TIMES IN NICU. I QUICKLY FOUND OUT THAT TRYING TO GET A HAT WITHOUT MUCH STRETCH ON A WET, GOOEY HEAD IS WHAT I CALL A FAILURE. BABY WAS FINE WITH MY QUICK TRIAL BECAUSE I FIRST PUT INCA SETUP ON TO STABILIZE PT. BUT WITH INCA SETUP FALLING APART TWICE I THOUGHT GOOD TIME TO TRY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255956 INCA 9F COMPLETE SET INCA 9F COMPLETE SET BZD COOPERSURGICAL, INC. 44-2709DF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1