BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 23199573 · Received October 2, 2025

    Report

    Report Number
    3002806821-2025-00078
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 26, 2025
    Report Date
    December 9, 2025
    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

    THE MODEL NUMBER INFORMATION WAS NOT REPORTED OR NOT KNOWN BY THE REPORTER. HENCE, WE CANNOT DEFINITIVELY DETERMINE THE MODEL WITH THE INFORMATION PROVIDED. MODEL 2 WAS SELECTED AS THERE IS A MUCH HIGHER PROBABILITY THAT THIS MODEL WAS USED AS ORGANON IS CURRENTLY ONLY MANUFACTURING/MARKETING THIS MODEL. THE DEVICE IS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAS BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION MAY BE PERFORMED. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Additional Manufacturer Narrative · 0

    THE MODEL NUMBER INFORMATION WAS NOT REPORTED OR NOT KNOWN BY THE REPORTER. HENCE, WE CANNOT DEFINITIVELY DETERMINE THE MODEL WITH THE INFORMATION PROVIDED. MODEL 2 WAS SELECTED AS THERE IS A MUCH HIGHER PROBABILITY THAT THIS MODEL WAS USED AS ORGANON IS CURRENTLY ONLY MANUFACTURING/MARKETING THIS MODEL.

    Description of Event or Problem · 0

    FOLLOW UP REPORT RECEIVED ON 04-DEC-2025. THIS IS A FINAL REPORT. MANUFACTURING STATEMENT: NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER ARE AVAILABLE FOR EVALUATION, THEREFORE AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE IS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS ARE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAS BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED AND ADDITIONAL INVESTIGATION MAY BE PERFORMED. THIS IS ONE OF SEVERAL REPORTS RECEIVED FROM THE SAME REPORTER.

    Description of Event or Problem · 0

    THE GREEN PART THAT GOES INTO THE PATIENT'S CERVIX WAS GETTING CLOGGED WITH CLOTS [DEVICE OCCLUSION]. THE JADA WORKED WITHOUT ISSUE, BUT THE BLEEDING CONTINUED [DEVICE INEFFECTIVE]. NO ADDITIONAL AES REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM THE OFFICE MANAGER REFERRING TO A 37-YEAR-OLD FEMALE PATIENT. THE PATIENT'S OBSTETRIC HISTORY INCLUDED MULTIGRAVIDA (GRAVIDA 3) AND MULTIPAROUS (PARA 2). THE PATIENT'S MEDICAL HISTORY INCLUDED DELIVERY AND PREGNANCY (SINGLETON). THE PATIENT'S PAST DRUG REACTIONS/ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON (B)(6) 2025, THE PATIENT WAS PLACED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) VIA TRANSVAGINAL ROUTE (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. THE GREEN PART THAT WENT INTO THE PATIENT'S CERVIX WAS GETTING CLOGGED WITH CLOTS (DEVICE OCCLUSION) AND HAD TO USE SECOND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) BECAUSE OF THE CLOTS AND THE CLOGGING (DEVICE INEFFECTIVE). THE PATIENT WAS HOSPITALIZED APPROXIMATELY IN (B)(6) 2025. THE SECOND VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) STOPPED THE BLEEDING. NO ADDITIONAL INTERVENTIONS WERE NEEDED AFTER VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) TO CONTROL THE ABNORMAL POSTPARTUM UTERINE BLEEDING OR HEMORRHAGE. THE DEVICE WAS DISCARDED. NO ADDITIONAL ADVERSE EVENTS (AES) REPORTED (NO ADVERSE EVENT). NO PRODUCT QUALITY COMPLAINTS (PQCS) REPORTED. THE REPORTER CONSIDERED THE DEVICE OCCLUSION AND DEVICE INEFFECTIVE WAS SERIOUS DUE TO LIFE THREATENING. UPON INTERNAL REVIEW, THE EVENTS DEVICE OCCLUSION AND DEVICE INEFFECTIVE WAS DETERMINED TO BE SERIOUS DUE TO REQUIRED INTERVENTION (DEVICES). MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. THIS IS ONE OF SEVERAL REPORTS RECEIVED FROM THE SAME REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319677 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON LLC JADA-2002 00840164521139

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Life Threatening| H| R