BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 13952332 · Received March 30, 2022

    Report

    Report Number
    3017425145-2022-00049
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    February 26, 2022
    Report Date
    March 30, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE OVERALL INFORMATION CURRENTLY PROVIDED IN THIS REPORT, THERE IS NO CLEAR EVIDENCE THAT THE JADA SYSTEM HAS CAUSED OR CONTRIBUTED TO THE OCCURRENCE OF A POTENTIAL MALFUNCTION AND/ OR SERIOUS INJURY. THE CASE IS CONFOUNDED BY THE REPORTED BLOOD CLOTS (REPORTED AS "JADA REMOVED, CLOTS EVACUATED"). PER THE JADA SYSTEM IFU "EVALUATE FOR LACERATIONS, RETAINED PRODUCTS OF CONCEPTION, OR OTHER CAUSES OF BLEEDING PRIOR TO USING JADA.", "JADA IS NOT A SUBSTITUTE FOR SURGICAL MANAGEMENT AND FLUID RESUSCITATION OF LIFE-THREATENING PPH/ABNORMAL POSTPARTUM UTERINE BLEEDING "AND "SIGNS OF PATIENT DETERIORATION OR FAILURE TO IMPROVE INDICATE THE NEED FOR REASSESSMENT AND POSSIBLY MORE AGGRESSIVE TREATMENT AND MANAGEMENT OF POSTPARTUM HEMORRHAGE (PPH)/ABNORMAL POSTPARTUM UTERINE BLEEDING." HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, THIS CASE WILL BE REPORTED AS A SERIOUS INJURY MDR.

    Description of Event or Problem · 0

    ALYDIA HEALTH RECEIVED A JADA EXPERIENCE SURVEY (JES) ON MARCH 02, 2022, THAT REPORTED JADA STOPPED THE POSTPARTUM HEMORRHAGE (PPH) IN "GREATER THAN 10 MINUTES," AND NOTED "JADA REMOVED, CLOTS EVACUATED. JADA REPLACED AND MOVED TO DIFFERENT SUCTION WITH SUCCESS" IN THE AREA ON THE SURVEY DESIGNATED FOR FEEDBACK WHEN 'JADA DID NOT STOP BLEEDING'. THE PATIENT IN THIS CASE IS DESCRIBED AS HAVING OBESITY AND PRE-ECLAMPSIA. HER PPH STARTED WITHIN ONE HOUR AFTER DELIVERY. THE PATIENT'S DELIVERY IS DESCRIBED AS, "C-SECTION - 3.5-DAY 10L, PT. REFUSED TO PUSH." THE AMOUNT OF BLOOD LOST PRIOR TO JADA USE WAS NOTED AS "1800 ML" , WHICH IS SEVERE PPH. PRIOR TO JADA TREATMENT SHE RECEIVED CYTOTEC (ONE UNIT) AND HEMABATE (ONE UNIT). A JADA DEVICE WAS PLACED ON (B)(6) 2022. THE CERVICAL SEAL WAS FILLED WITH 120 ML OF STERILE FLUID. THE AMOUNT OF BLOOD EVACUATED WITH THE JADA WAS 300 ML. THERE IS NO OTHER INFORMATION FOR THIS CASE PROVIDED ON THIS SURVEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2903334 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female