BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 13118960 · Received December 30, 2021

    Report

    Report Number
    3017425145-2021-00042
    Event Type
    Injury
    Date Received
    December 30, 2021
    Report Date
    December 29, 2021
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LOT NUMBER IS NOT CURRENTLY AVAILABLE FOR THIS EVENT. REQUEST SENT TO SITE FOR LOT NUMBER, NO RESPONSE TO THIS REQUEST TO DATE. A GOOD FAITH EFFORT TO OBTAIN LOT NUMBER HAS BEEN ATTEMPTED. THIS REPORT WILL BE AMENDED IF WE RECEIVE ADDITIONAL INFORMATION REGARDING THIS EVENT. WE DO NOT HAVE ALL THE DETAILS OF THIS EVENT. TYPICALLY, D&C IS PERFORMED IN THE PRESENCE OF PPH IF THERE IS CONTINUED BLEEDING DUE TO RETAINED PRODUCTS OF CONCEPTION AND/OR LARGE CLOTS. THE SURVEY FORM NOTED THAT RETAINED PRODUCTS WERE PRESENT IN THIS EVENT. WE ARE UNAWARE IF EFFORTS WERE MADE TO REMOVE BLOOD CLOTS/RETAINED PRODUCTS PRIOR TO JADA INSERTION, IF AN ULTRASOUND WAS CONDUCTED WHILE JADA WAS IN PLACE AND IF THAT IS HOW THEY DETERMINED THERE WERE CLOTS/ RETAINED PRODUCTS OR IF THEY NOTED ANY CLOTS/RETAINED PRODUCTS AFTER THEY REMOVED THE JADA DEVICE, WHETHER THEY NEEDED TO DO A D&C TO CONTROL HER PPH AFTER JADA WAS REMOVED, AND IF THE D&C STOPPED THE PPH. JADA WAS USED AS A TREATMENT INTERVENTION WITH A PATIENT EXPERIENCING SEVERE PPH THAT UTEROTONICS HAD FAILED TO STOP. THE DEVICE LABELING STATES THE INDICATION FOR USE OF JADA IS "TO PROVIDE CONTROL AND TREATMENT OF ABNORMAL POSTPARTUM UTERINE BLEEDING OR HEMORRHAGE WHEN CONSERVATIVE MANAGEMENT IS WARRANTED." WARNINGS PROVIDED ON THE JADA LABELING STATE THAT "FAILURE TO IMPROVE INDICATES THE NEED FOR REASSESSMENT AND POSSIBLY MORE AGGRESSIVE TREATMENT AND MANAGEMENT OF PPH" AND "JADA IS NOT A SUBSTITUTE FOR SURGICAL INTERVENTION AND FLUID RESUSCITATION OF LIFE-THREATENING PPH." THE SERIOUS INJURY IN THIS CASE WAS THE MEDICAL INTERVENTION OF D&C TO REMOVE RETAINED PRODUCTS OF CONCEPTION AFTER JADA TREATMENT. THE PATIENT IN THIS CASE WAS EXPERIENCING SEVERE PPH. THE SERIOUS INJURY LISTED ABOVE FOR THIS EVENT IS STANDARD TREATMENT OF PPH TO CONTROL A PATIENT'S BLEEDING AND REMOVE RETAINED PRODUCTS OF CONCEPTION AND MEDICALLY STABILIZE THE PATIENT. AS WE ARE UNABLE TO RULE OUT THE USE OF JADA IN CONTRIBUTING TO THE NEED TO TREAT THE PATIENT WITH A D&C, WE ARE REPORTING THIS AS A MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 0

    ALYDIA HEALTH EMPLOYEE RECEIVED A COMPLETED JADA EXPERIENCE SURVEY FORM THAT REPORTED JADA DID NOT STOP THE POSTPARTUM HEMORRHAGE (PPH) AND NOTED, "NEEDED D&C (DILATATION AND CURETTAGE) FOR RETAINED PRODUCTS" IN THE AREA ON THE SURVEY DESIGNATED FOR FEEDBACK WHEN 'JADA DID NOT STOP BLEEDING'. THE EVENT DATE FOR THIS SURVEY WAS NOT NOTED, AND THE SURVEY WAS RECEIVED BY ALYDIA HEALTH ON (B)(6) 2021. THE INFORMATION PROVIDED FOR THIS EVENT IS LIMITED AND STATES THAT THE PATIENT HAD A SCHEDULED CESAREAN SECTION (C-SECTION) DELIVERY. THIS PATIENT'S PPH STARTED WITHIN ONE HOUR AFTER DELIVERY (A CATEGORICAL CHECKBOX) AND THE AMOUNT OF BLOOD LOSS WAS LISTED AS 2335 ML PRIOR TO JADA USE. THE SURVEY FORM INDICATES THAT PRIOR TO USING JADA, THIS PATIENT'S PPH WAS TREATED WITH UNKNOWN DOSES OF HEMABATE, TXA, METHERGINE, CYTOTEC, SURGICAL, PITOCIN, ARISTA AND GELFOAM. THERE IS INFORMATION NOTED AS "NOT APPLICABLE (N/A)" ON THIS SURVEY FORM, INCLUDING ABOUT HOW LONG JADA WAS IN PLACE OR HOW MUCH BLOOD WAS EVACUATED INTO THE JADA COLLECTION CANISTER. THIS SURVEY FORM DOES NOT HAVE ANY OTHER INFORMATION THAT WAS PROVIDED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016008 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA-1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other