BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 23015040 · Received September 10, 2025

    Report

    Report Number
    3002806821-2025-00073
    Event Type
    Injury
    Date Received
    September 10, 2025
    Date of Event
    August 13, 2025
    Report Date
    November 27, 2025
    Manufacturer
    ORGANON LLC
    Product Code
    OQY
    UDI-DI
    00840164521139
    PMA / PMN Number
    K212757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL DEVICE REPORTABILITY CODES: ANNEXES A-G - G07003 - INSUFFICIENT COMPONENT INFORMATION. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Additional Manufacturer Narrative · 0

    THIS IS AN AMENDED REPORT: DELETED CURRENT CONDITION C-SECTION WOUND DEHISCENCE AND EVENT NO ADVERSE EVENT. ADDED EVENT PT: WOUND DEHISCENCE FOR C-SECTION WOUND DEHISCENCE. THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    FOLLOW UP RECEIVED ON 25-NOV-2025. THIS IS FINAL DEVICE RELATED REPORT. NO COMPLAINT SAMPLE OR DEVICE LOT NUMBER WERE AVAILABLE FOR EVALUATION; THEREFORE, AN UNKNOWN INVESTIGATION WAS PERFORMED. THE DEVICE WAS ASSEMBLED PER SPECIFICATIONS WHERE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED BY TRAINED PERSONNEL. NO OUTCOME FROM THE INVESTIGATION COULD BE DETERMINED SINCE NO COMPLAINT SAMPLE OR LOT IDENTIFICATION HAD BEEN PROVIDED. IF THE COMPLAINT SAMPLE OR LOT NUMBER BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, AND ADDITIONAL INVESTIGATION MAY BE PERFORMED.

    Description of Event or Problem · 0

    AFTER A FEW MINUTES THE PATIENT BEGAN BLEEDING WITH A LOT OF CLOTS OUT OF VAGINA AND AROUND THE SEAL [DEVICE INEFFECTIVE]. NO ADDITIONAL AE, NO PQC REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A REGISTERED NURSE REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE VIA CLINICAL EDUCATION SPECIALIST (CES). THE PATIENT HAD PREVIOUS CESAREAN SECTION. DURING THE SURGERY ON (B)(6) 2025, AFTER OPENING ABDOMEN AND VISUALIZED THE UTERINE WALL, THEY DISCOVERED THE UTERINE WALL WAS SO THIN THEY COULD SEE THE BABY DESCRIBING IT AS A WINDOW. THE BABY WAS ACCESSED THROUGH THE PREVIOUS CESAREAN INCISION AND REMOVED THE BABY. THEY SUTURED THE UTERUS AND ABDOMEN CLOSED AND SOON AFTER, THE PATIENT BEGAN BLEEDING, WHICH CLINICAL EDUCATION SPECIALIST (CES) STATED WAS NOT UNUSUAL FOR A UTERUS SO THIN. THE PATIENT'S CONCURRENT CONDITIONS, 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) 2.0 THROUGH THE CERVIX VIA INTRAUTERINE ROUTE (LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR POST-PARTUM HEMORRHAGE. IT WAS INITIALLY WORKING WELL. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS USED WITH UNKNOWN SUCTION SETTING OR CERVICAL SEAL STERILE WATER VOLUME BUT STATED THAT IT WAS THE MAXIMUM AMOUNT. AFTER A FEW MINUTES THE PATIENT BEGAN BLEEDING WITH A LOT OF CLOTS OUT OF VAGINA AND AROUND THE SEAL (DEVICE INEFFECTIVE). THE CLINICAL EDUCATION SPECIALIST (CES) WAS NOT INFORMED OF THE TOTAL VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) TIME BUT STATED IT WAS LESS THAN AN HOUR. THE PROVIDER REMOVED THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) AND PATIENT WENT BACK TO THE OPERATION ROOM (OR) AND IT WAS DISCOVERED THE CESAREAN SECTION WOUND WAS DEHISCING OR OPENING BACK UP. THE PATIENT ULTIMATELY ENDED WITH A HYSTERECTOMY. THE CLINICAL EDUCATION SPECIALIST (CES) STATED THAT THERE WAS NO COMPLICATION WITH THE USE OF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WORKED WITHOUT ISSUE, BUT THE BLEEDING CONTINUED. THE DEVICE WAS NOT REMOVED AND REINSERTED FOR ANY REASON. NO ADDITIONAL ADVERSE EVENT (AE) (ADVERSE EVENT), NO PRODUCT QUALITY COMPLAINT (PQC) REPORTED. THE OUTCOME OF DEVICE INEFFECTIVE WAS UNKNOWN. UPON INTERNAL REVIEW, THE EVENT DEVICE INEFFECTIVE WAS DETERMINED TO BE SERIOUS DUE TO REQUIRED INTERVENTION (DEVICES).

    Description of Event or Problem · 0

    THIS IS AN AMENDED REPORT: DELETED CURRENT CONDITION C-SECTION WOUND DEHISCENCE AND EVENT NO ADVERSE EVENT. ADDED EVENT PT: WOUND DEHISCENCE FOR C-SECTION WOUND DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488954 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON LLC JADA-2002 00840164521139

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O