BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 13743426 · Received March 12, 2022

    Report

    Report Number
    3017425145-2022-00032
    Event Type
    Injury
    Date Received
    March 12, 2022
    Date of Event
    February 5, 2022
    Report Date
    March 11, 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 FOR THIS REPORT, A POSSIBLE CONTRIBUTING OR CAUSAL ROLE OF THE JADA SYSTEM AND THE NEED FOR ESCALATING TREATMENT (UAE [UTERINE ARTERY EMBOLIZATION]) 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." AND "EVALUATE FOR LACERATIONS, RETAINED PRODUCTS OF CONCEPTION, OR OTHER CAUSES OF BLEEDING PRIOR TO USING JADA." 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 02/10/2022, THAT REPORTED JADA DID NOT STOP THE POSTPARTUM HEMORRHAGE (PPH) AND NOTED, "UTERINE ARTERY EMBOLIZATION" IN THE AREA ON THE SURVEY DESIGNATED FOR FEEDBACK WHEN 'JADA DID NOT STOP BLEEDING'. THE PATIENT IN THIS CASE IS DESCRIBED AS HAVING A "TRAUMATIC D&E" AND "TOP BY D&E" NO OTHER DETAILS REGARDING PREGNANCY OR DELIVERY ON 02/05/2022. HER PPH STARTED WITHIN ONE HOUR AFTER DELIVERY. THE AMOUNT OF BLOOD LOST PRIOR TO JADA USE WAS NOTED AS "200 ML FROM PRESENTATION TO ER, SOAKED 4-6 PADS/HOUR FOR 5 HOURS PRIOR." PRIOR TO JADA TREATMENT SHE RECEIVED UNKNOWN AMOUNTS OF BLOOD PRODUCTS, LISTED ONLY AS "MASSIVE BLOOD TRANSFUSION", CYTOTEC (100 MCG), HEMABATE (ONE DOSE), METHERGINE (1 DOSE), AND TXA (1 DOSE). THE CERVICAL SEAL WAS FILLED WITH 120 ML OF STERILE FLUID. THE AMOUNT OF BLOOD EVACUATED WITH THE JADA WAS 1500 ML. THERE IS NO OTHER INFORMATION FOR THIS CASE PROVIDED ON THIS SURVEY. THERE IS LIMITED INFORMATION FOR THIS JES. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE ON 02/23/2022 AND 03/11/2022, TO INQUIRE IF THE LOT NUMBER WAS AVAILABLE, IF THE DEVICE WAS RETAINED, AND FOLLOW UP QUESTIONS REGARDING THIS CASE. TO DATE WE HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THIS CASE, WE WILL AMEND THIS REPORT IF WE RECEIVE ANY FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972703 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other