BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 14106340 · Received April 13, 2022

    Report

    Report Number
    3017425145-2022-00060
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 12, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE OVERALL INFORMATION CURRENTLY AVAILABLE IN THIS REPORT, THERE IS NO CLEAR EVIDENCE AT THIS TIME THAT THE JADA SYSTEM CAUSED OR CONTRIBUTED TO THE OCCURRENCE OF A POTENTIAL MALFUNCTION REPORTED AS "DIFFICULT PLACEMENT". THIS REPORT WILL BE AMENDED AS APPROPRIATE IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE EVENT. HOWEVER; OUT OF AN ABUNDANCE OF CAUTION, THIS CASE WILL BE REPORTED AS A MALFUNCTION MDR. 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.JADA IS NOT A SUBSTITUTE FOR SURGICAL MANAGEMENT AND FLUID RESUSCITATION OF LIFE-THREATENING PPH/ABNORMAL POSTPARTUM UTERINE BLEEDING. PLACE JADA SUCH THAT THE INTRAUTERINE LOOP IS LOCATED IN THE UTERUS AND IS ORIENTED IN THE FRONTAL PLANE OF THE BODY BY ASSURING THE SEAL VALVE IS ORIENTED AT EITHER 6 OR 12 O'CLOCK. ULTRASOUND MAY BE USED TO CONFIRM PROPER PLACEMENT OF THE INTRAUTERINE LOOP WITHIN THE UTERUS AND AFTER INSERTION, THE INTRAUTERINE LOOP SHOULD BE WITHIN THE UTERUS WHILE THE CERVICAL SEAL SHOULD BE LOCATED WITHIN THE VAGINA AT THE EXTERNAL CERVICAL OS.

    Description of Event or Problem · 0

    PLEASE SEE JADE EXPERIENCE SURVEY (JES). ALYDIA HEALTH/ORGANON RECEIVED A JADA EXPERIENCE SURVEY (JES) THAT REPORTED NO INFORMATION IN THE AREA DESIGNATED FOR HOW QUICKLY DID JADA STOP THE POSTPARTUM HEMORRHAGE (PPH) AND NOTED DIFFICULT PLACEMENT. FIRST ATTEMPT UNSUCCESSFUL. FOUND TO BE IN POSTERIOR VAGINAL VAULT VIA U/S. SECOND ATTEMPT DR. XX TIP OF SYSTEM IN LOWER SEGMENT ON U/S. BLOOD RETURN IN TUBING. BLEEDING WELL CONTROLLED" IN THE AREA ON THE SURVEY DESIGNATED FOR FEEDBACK WHEN JADA DID NOT STOP BLEEDING. THE JES INDICATES THAT THE PATIENT IN THIS CASE HAD PPH THAT STARTED WITHIN ONE HOUR AFTER AN INDUCED VAGINAL DELIVERY. THE PATIENT IS DESCRIBED OBESE. PRIOR TO JADA PLACEMENT THE PATIENT WAS TREATED WITH METHERGINE (ONE UNIT) TXA (ONE UNIT) AND "ADDITION 10 OF PITOCIN ADDED TO PP BAG." HER BLOOD LOSS PRIOR TO JADE TREATMENT WAS 1500 ML. THE JADA SYSTEM WAS PLACED (B)(6) 2022. THE CERVICAL SEAL WAS FILLED WITH 60 ML OF STERILE FLUID. THE AMOUNT OF BLOOD EVACUATED WITH JADA WAS LESS THAN 50 ML. THERE IS NO OTHER INFORMATION PROVIDED ON THIS JES. THIS SITE DOES NOT RECORD LOT NUMBERS OF THE JADA DEVICES USED. AN EMAIL REQUEST WAS SENT TO THIS SITE (B)(6) 2022. CONFIRMING THEY HAVE NOT RETAINED A LOT NUMBER OR THE DEVICE AND REQUESTING FOLLOW UP INFORMATION FOR THIS CASE. THIS REPORT WILL BE AMENDED IF FURTHER INFORMATION IS PROVIDED. FOLLOWING THE ATTEMPT TO TREAT PPH THAT UTEROTONICS FAILED TO TREAT, A JADA DEVICE WAS INSERTED. THE HEALTH CARE PROVIDER VERIFIED PLACEMENT WITH ULTRASOUND, ADJUSTED THE JADA PLACEMENT AND REPORTED "BLEEDING WELL CONTROLLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654476 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female