BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 13934587 · Received March 28, 2022

    Report

    Report Number
    3017425145-2022-00043
    Event Type
    Injury
    Date Received
    March 28, 2022
    Date of Event
    December 23, 2021
    Report Date
    March 28, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE OVERALL INFORMATION CURRENTLY AVAILABLE IN THIS REPORT, THERE IS NO CLEAR EVIDENCE THAT THE JADA SYSTEM CAUSED OR CONTRIBUTED TO THE NEED FOR ANY INTERVENTIONS (INCLUDING MASSIVE TRANSFUSION PROTOCOL) TO PRECLUDE PERMANENT BODY DAMAGE/IMPAIRMENT. THE REPORTED UNDIAGNOSED PLACENTA INCRETA MAY PROVIDE A MORE PLAUSIBLE ALTERNATIVE EXPLANATION FOR THE UNCONTROLLED ABNORMAL POST-PARTUM BLEEDING. PER THE JADA SYSTEM IFU: "PRECAUTION: THE SAFETY AND EFFECTIVENESS OF THE USE OF JADA IN PATIENTS WITH PLACENTA ACCRETA HAVE NOT BEEN EVALUATED.", "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." HOWEVER, 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 (B)(6) 2022, THAT REPORTED JADA DID NOT STOP THE POSTPARTUM HEMORRHAGE (PPH) AND NOTED, "PT. HAD UNDIAGNOSED INCRETA, THUS JADA DID NOT WORK" IN THE AREA ON THE SURVEY DESIGNATED FOR FEEDBACK WHEN 'JADA DID NOT STOP BLEEDING'. THE PATIENT IN THIS CASE IS DESCRIBED AS MULTIPAROUS AND OBESE, CURRENT PREGNANCY IS MULTIPLES WITH PRE-ECLAMPSIA. HER PPH STARTED ON (B)(6) 2021, WITHIN ONE HOUR AFTER AN EMERGENCY CESAREAN SECTION DELIVERY. THE AMOUNT OF BLOOD LOST PRIOR TO JADA WAS "2.5 L TO 3.0 L." PRIOR TO JADA TREATMENT SHE RECEIVED UNKNOWN DOSAGES OF HEMABATE, CYTOTEC AND TXA. AFTER JADA INSERTION THE PATIENT RECEIVED UNKNOWN AMOUNTS OF PACKED RED BLOOD CELLS, FRESH FROZEN PLASMA, AND MAJOR TRANSFUSION PROTOCOL WAS INITIATED. TOTAL BLOOD LOSS AFTER USE OF JADA WAS NOTED AS "UNSURE." THERE IS NO OTHER INFORMATION FOR THIS CASE PROVIDED ON THIS SURVEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25019 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other