BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 11868797 · Received May 23, 2021

    Report

    Report Number
    3017425145-2021-00009
    Event Type
    Malfunction
    Date Received
    May 23, 2021
    Report Date
    May 23, 2021
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THE REPORT THAT JADA SEEMED CLOTTED, JADA SUCCESSFULLY TREATED THIS PATIENT'S POSTPARTUM HEMORRHAGE. IT IS UNCLEAR WHETHER THE JADA MALFUNCTIONED BASED ON THE INFORMATION THAT IS AVAILABLE AT THIS TIME, BUT OUT OF AN ABUNDANCE OF CAUTION AND BECAUSE WE CANNOT RULE IT OUT AT THIS TIME, WE ARE REPORTING THIS EVENT DUE TO THE 30-DAY REPORTING DEADLINE. IF WE BECOME AWARE OF ADDITIONAL INFORMATION, WE WILL SUPPLEMENT THIS REPORT. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    JADA WAS REPORTED AS WORKING TO TREAT ATONY AND BLEEDING AND THE PATIENT WAS THEN TRANSPORTED TO THE OR TO TREAT A 4TH DEGREE VAGINAL LACERATION. FOR TRANSPORT, JADA WAS LEFT IN PLACE, AND WAS DISCONNECTED FROM VACUUM TUBING AND THE TUBING WAS PLACED UNDER THE PATIENT'S LEG. UPON RECONNECTION TO VACUUM IN THE OR, NO ADDITIONAL BLOOD FLOW WAS OBSERVED THROUGH JADA AND IT WAS SUSPECTED THAT THE DEVICE OR TUBING MAY HAVE BECOME CLOTTED. NO ESCALATION OF CARE WAS NECESSARY, BUT JADA USE WAS DISCONTINUED AFTER THIS WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765257 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA-1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR