BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 18666777 · Received February 8, 2024

    Report

    Report Number
    3002806821-2024-00004
    Event Type
    Injury
    Date Received
    February 8, 2024
    Report Date
    February 8, 2024
    Manufacturer
    ORGANON & CO.
    Product Code
    OQY
    PMA / PMN Number
    510K K201199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION WE HAVE RECEIVED, THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THE DEVICE IS ASSEMBLED ACCORDING TO SPECIFICATIONS. IN PROCESS AND FINISHED PRODUCT TESTING ARE PERFORMED AND APPROVED PRIOR TO RELEASE.

    Description of Event or Problem · 0

    PATIENT CONTINUED TO BLEED AROUND THE CERVICAL SEAL [DEVICE INEFFECTIVE]. NO ADDITIONAL ADVERSE EVENT (AE) REPORTED [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A NURSE VIA CLINICAL ACCOUNT SPECIALIST (CAS) REFERRING TO A FEMALE (CONSERVATIVELY) PATIENT OF UNKNOWN AGE AND GENDER. THE PATIENT'S CURRENT CONDITION, HISTORICAL CONDITION, CONCOMITANT MEDICATIONS AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT(S) AND 1 DEVICE(S). ON UNKNOWN DATE, THE PATIENT UNDERWENT INSERTION WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) (ROUTE, LOT #, SERIAL # AND EXPIRATION DATE WERE NOT REPORTED) FOR POSTPARTUM HEMORRHAGE. ON AN UNKNOWN DATE, CLINICAL ACCOUNT SPECIALIST REPORTED THAT VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS PLACED FOR POSTPARTUM HEMORRHAGE AND BLEEDING WAS NOT CONTAINED. PATIENT CONTINUED TO BLEED AROUND THE CERVICAL SEAL. UTERINE ARTERY EMBOLIZATION PERFORMED. PATIENT REQUIRED INTENSIVE CARE UNIT ADMISSION AND HAD SINCE RECOVERED AND BEEN DISCHARGED. NO ADDITIONAL ADVERSE EVENT (AE) REPORTED (NO ADVERSE EVENT). NO ADDITIONAL DETAILS KNOWN. THERAPY WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS UNKNOWN. UPON INTERNAL REVIEW, THE EVENT OF DEVICE INEFFECTIVE WAS CONSIDERED AS SERIOUS DUE TO THE REQUIRED INTERVENTION (DEVICES). MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. WHEN THE LOT NUMBER IS UNKNOWN, A TECHNICAL INVESTIGATION OF THE SPECIFIC MANUFACTURING PROCESS WHICH INCLUDES REVIEW OF RECORDS ASSOCIATED WITH A KNOWN LOT NUMBER CANNOT BE PERFORMED. FDA CODE: (HEALTH EFFECTS - HEALTH IMPACT PER ANNEX F): 4608 INTENSIVE CARE (PATIENT REQUIRES ADMISSION TO OR EXTENSION OF STAY IN AN INTENSIVE CARE UNIT.) FDA CODE: (HEALTH EFFECTS - HEALTH IMPACT PER ANNEX F): 4624 SURGICAL INTERVENTION (ONE OR MORE SURGICAL PROCEDURES WAS REQUIRED, OR AN EXISTING PROCEDURE CHANGED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278557 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention