BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 14116435 · Received April 14, 2022

    Report

    Report Number
    3017425145-2022-00063
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 18, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 OCCURRENCE OF A POTENTIAL MALFUNCTION AND/OR SERIOUS INJURY. THE LACK OF ADEQUATE CERVICAL DILATION (REPORTED AS "NOT DILATED DR MANUALLY OPENED CERVIX TO 1 CM ") MAY PROVIDE AN ALTERNATIVE EXPLANATION FOR THE REPORTED DIFFICULT INSERTION OF THE JADA SYSTEM. PER THE JADA SYSTEM IFU SECURE VISUALIZATION OF THE CERVIX TO CONFIRM IT IS DILATED GREATER THAN 3 CM TO ALLOW FOR PLACEMENT OF JADA. AND FOR C-SECTIONS: IT IS CONTRAINDICATED FOR CERVIX 3 CM DILATED BEFORE USE OF JADA HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, THE COMPANY WILL REPORT THIS CASE AS A MALFUNCTION MDR.

    Description of Event or Problem · 0

    ALYDIA HEALTH RECEIVED A COMPLETED JADA EXPERIENCE SURVEY FORM THAT REPORTED JADA STOPPED THE POSTPARTUM HEMORRHAGE (PPH) AND NOTED, "IT WAS DIFFICULT INSERTING A PT WAS A C/S AND NOT DILATED DR MANUALLY OPENED CERVIX TO 1 CM" HANDWRITTEN ON THE BOTTOM OF THE SURVEY. THE PATIENT IN THIS CASE IS DESCRIBED AS HAVING A MEDICAL HISTORY SIGNIFICANT FOR MORBID OBESITY (GREATER THAN 400 LBS.) AND IN VITRO FERTILIZATION. HER POSTPARTUM HEMORRHAGE (PPH) STARTED WITHIN ONE HOUR AFTER A SCHEDULED CESAREAN SECTION (C-SECTION) DELIVERY. THE PATIENT'S BLOOD LOSS PRIOR TO JADA USE WAS REPORTED AS 3284 ML, WHICH IS SEVERE PPH. PRIOR TO JADA TREATMENT SHE RECEIVED HEMABATE (250 MCG IM) AND CYTOTEC (1000 MCG RECTALLY). THE RESIDENT MANUALLY EXPRESSED 1400 ML OF CLOTS AND PLACED A JADA SYSTEM IN THE OPERATING ROOM. THE PATIENT'S CERVIX WAS NOT DILATED FOLLOWING THE C-SECTION, AND THE RESIDENT MANUALLY OPENED THE PATIENT'S CERVIX THEN INSERTED THE JADA DEVICE. THE JES STATES IT WAS ONE CM. THE ATTENDING PHYSICIAN STATED SHE BELIEVE IT THE DILATION WAS "GREATER THAN ONE CM", BUT WAS NOT PRESENT. AFTER THE JADA WAS PLACED, THEY REPORTED JADA CONTROLLED THE PPH IN ONE TO FIVE MINUTES. THERE WAS 300 ML OF BLOOD EVACUATED WITH JADA. THE SITE DID PROVIDE SOME ADDITIONAL MINOR DETAILS TO THIS CASE, STATED THAT THE DEVICE THAT WAS USED WAS DISCARDED, AND THEY ARE NOT ABLE TO LOCATE/HAVE NOT RECORDED A LOT NUMBER FOR THE DEVICE THAT WAS UTILIZED FOR THIS CASE. A GOOD FAITH EFFORT HAS BEEN MADE TO ATTEMPT TO OBTAIN THIS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168173 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female