BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADA SYSTEM

    MDR report key: 23706014 · Received December 3, 2025

    Report

    Report Number
    3002806821-2025-00080
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ORGANON LLC
    Product Code
    OQY
    UDI-DI
    00840164521139
    PMA / PMN Number
    K212757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING INFORMATION INDICATED THAT 120 ML WAS PUT IN THE CERVICAL SEAL AND ONLY 80 ML WAS REMOVED VIA A SYRINGE. THIS SUGGESTS THAT THERE IS A POTENTIAL LEAKAGE FROM THE CERVICAL SEAL. HOWEVER, ROOT CAUSE OF THE CERVICAL SEAL LEAKAGE CANNOT BE INVESTIGATED AND CONFIRMED SINCE THE JADA SYSTEM WAS DISCARDED. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Additional Manufacturer Narrative · 0

    REPORTING INFORMATION INDICATED THAT 120 ML WAS PUT IN THE CERVICAL SEAL AND ONLY 80 ML WAS REMOVED VIA A SYRINGE. THIS SUGGESTS THAT THERE IS A POTENTIAL LEAKAGE FROM THE CERVICAL SEAL. HOWEVER, ROOT CAUSE OF THE CERVICAL SEAL LEAKAGE CANNOT BE INVESTIGATED AND CONFIRMED SINCE THE JADA SYSTEM WAS DISCARDED. THIS IS AN AMENDMENT REPORT: THE ADVERSE EVENT CHECKBOX WAS UNCHECKED IN MEDWATCH INFO SUB TAB. THIS CASE HAS BEEN DOWNGRADED AFTER FURTHER REVIEW AND NO LONGER MEETS CRITERIA FOR A DEVICE REPORTABLE EVENT. THE MALFUNCTION CHECKBOX WAS INCORRECTLY SELECTED EARLIER AND WOULD BE UPDATED CORRECTLY AFTER THIS ONE LAST SUBMISSION. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10

    Description of Event or Problem · 0

    THEY NOTICED A WATERY BLOOD-TINGED LEAKAGE [DEVICE LEAKAGE]. NO ADDITIONAL AE/PQC REPORTED. [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM THE NURSE MANAGER REFERRING TO FEMALE PATIENT VIA CLINICAL ACCOUNT SPECIALIST. THE PATIENT MEDICAL HISTORY, CONCURRENT CONDITION, PAST DRUG ALLERGY AND CONCOMITANT MEDICATION WAS NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON AN UNKNOWN DATE, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) 2.0 VIA INTRAVAGINAL ROUTE (DEFAULTED) (LOT #, SERIAL # AND EXPIRATION DATE WAS NOT REPORTED) FOR AN UNKNOWN INDICATION. ON AN UNKNOWN DATE, VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS SUSPECTED TO BE LEAKING. AS PER THE CLINICAL ACCOUNT SPECIALIST 120 ML WAS PUT IN THE CERVICAL SEAL AND THEY NOTICED A WATERY BLOOD-TINGED LEAKAGE (DEVICE LEAKAGE). ONLY 80 ML WAS REMOVED VIA A SYRINGE. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS DISCARDED. NO ADDITIONAL ADVERSE EVENT (NO ADVERSE EVENT)/PRODUCT QUALITY COMPLAINT (PQC) WAS REPORTED. CASE COMMENTS: BASED ON THE CLINICALLY RELEVANT INFORMATION CURRENTLY AVAILABLE FOR THIS INDIVIDUAL CASE AND THE ASSESSMENT PER US DECISION TREE (DEVICE ONLY), THE CASE WAS CONSIDERED NOT REPORTABLE, SINCE THE INFORMATION DID NOT REASONABLY SUGGEST THAT THE PRODUCT MAY HAVE CAUSED/CONTRIBUTED TO OR LIKELY TO CAUSE/CONTRIBUTE TO DEATH OR ANY OF THE OTHER SERIOUS INJURIES/OUTCOMES OR NEEDED ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION BEYOND WHAT IS NORMALLY REQUIRED.

    Description of Event or Problem · 0

    THIS IS AN AMENDMENT REPORT: THE ADVERSE EVENT CHECKBOX WAS UNCHECKED IN MEDWATCH INFO SUB TAB. THIS CASE HAS BEEN DOWNGRADED AFTER FURTHER REVIEW AND NO LONGER MEETS CRITERIA FOR A DEVICE REPORTABLE EVENT. THE MALFUNCTION CHECKBOX WAS INCORRECTLY SELECTED EARLIER AND WOULD BE UPDATED CORRECTLY AFTER THIS ONE LAST SUBMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857630 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON LLC JADA-2002 00840164521139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female