BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 13847842 · Received March 22, 2022

    Report

    Report Number
    3017425145-2022-00037
    Event Type
    Injury
    Date Received
    March 22, 2022
    Date of Event
    January 1, 2022
    Report Date
    March 21, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE CASE IS CONFOUNDED BY CHORIOAMNIONITIS, BASED ON THE OVERALL INFORMATION CURRENTLY AVAILABLE FOR THIS REPORT, A POSSIBLE CONTRIBUTING OR CAUSAL ROLE OF THE JADA SYSTEM FOR THE NEED OF THE REPORTED ESCALATING TREATMENTS (HYSTERECTOMY) TO PRECLUDE PERMANENT BODY DAMAGE/IMPAIRMENT CANNOT BE EXCLUDED. PER THE JADA SYSTEM IFU, "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.", "EVALUATE FOR LACERATIONS, RETAINED PRODUCTS OF CONCEPTION, OR OTHER CAUSES OF BLEEDING PRIOR TO USING JADA." AND "JADA IS NOT A SUBSTITUTE FOR SURGICAL MANAGEMENT AND FLUID RESUSCITATION OF LIFE-THREATENING PPH/ABNORMAL POSTPARTUM UTERINE BLEEDING." OUT OF AN ABUNDANCE OF CAUTION, THE COMPANY WILL REPORT THIS CASE AS A SERIOUS INJURY MDR.

    Description of Event or Problem · 0

    ALYDIA HEALTH RECEIVED A JADA EXPERIENCE SURVEY (JES) ON 02/22/2022, THAT REPORTED JADA DID NOT STOP THE POSTPARTUM HEMORRHAGE (PPH) AND NOTED, "HYSTERECTOMY" IN THE AREA ON THE SURVEY DESIGNATED FOR FEEDBACK WHEN 'JADA DID NOT STOP BLEEDING'. THE PATIENT IN THIS CASE IS DESCRIBED AS HAVING CHORIOAMNIONITIS, GESTATIONAL DIABETES MELLITUS AND A HISTORY OF PREVIOUS CESAREAN SECTION. HER PPH STARTED ON (B)(6)2022, LESS THAN ONE HOUR AFTER A VAGINAL, VACUUM ASSISTED DELIVERY. THE AMOUNT OF BLOOD LOST PRIOR TO JADA USE WAS NOT NOTED. PRIOR TO JADA TREATMENT SHE RECEIVED UNKNOWN DOSAGES OF OXYTOCIN DOUBLE-CONCENTRATE HEMABATE, AND TXA. AFTER JADA INSERTION THE PATIENT RECEIVED UNKNOWN AMOUNTS OF PACKED RED BLOOD CELLS, FRESH FROZEN PLASMA, IT WAS NOTED THAT MAJOR TRANSFUSION PROTOCOL WAS INITIATED, AND HYSTERECTOMY. TOTAL BLOOD LOSS AFTER USE OF JADA WAS NOTED AS 3276 ML. THERE IS NO OTHER INFORMATION FOR THIS CASE PROVIDED ON THIS SURVEY. THERE IS LIMITED INFORMATION FOR THIS JES CURRENTLY. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE ON 02/28/2022 AND 03/21/2022, TO INQUIRE IF THE LOT NUMBER WAS AVAILABLE, IF THE DEVICE WAS RETAINED, AND FOLLOW UP QUESTIONS REGARDING THIS CASE. CURRENTLY THERE HAS BEEN NO RESPONSE TO REQUESTS FOR THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514501 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| S