BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 16901831 · Received May 10, 2023

    Report

    Report Number
    3002806821-2023-00050
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 20, 2023
    Report Date
    May 10, 2023
    Manufacturer
    ORGANON & CO.
    Product Code
    OQY
    PMA / PMN Number
    510K K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    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

    DIC [DISSEMINATED INTRAVASCULAR COAGULATION] . CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN VIA CLINICAL EDUCATOR REFERRING TO A NON-PREGNANT FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY AND HAD DELIVERY. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED PPH (POSTPARTUM HAEMORRHAGE), HER CONCOMITANT MEDICATIONS, AND PAST DRUG REACTIONS/ALLERGIES WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON (B)(6) 2023, THE PATIENT WAS INSERTED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM), INTRAVAGINALLY BY ATTENDING PHYSICIAN FOR POSTPARTUM HEMORRHAGE (POSTPARTUM HAEMORRHAGE). ON THE SAME DAY, THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) FOR HEMORRHAGE AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC) (DISCREPANCY: DIC WAS ALSO REPORTED AS MEDICAL HISTORY AND SUSPECTED CAUSE OF PPH). THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS STARTED LATE AND DID CONTROL THE BLEEDING. THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) LEFT IN PLACE FOR 24 HOURS. CLINICAL EDUCATOR WAS ASKED SHOULD ANTIBIOTICS BE INITIATED, AND PROVIDER WAS DIRECTED TO PEARL STUDY INFORMATION. PATIENT WAS GIVEN BLOOD TRANSFUSIONS/BLOOD PRODUCTS DURING PERIPARTUM. THE PATIENT SOUGHT MEDICAL ATTENTION AND SHE DID NOT DIE. THE AVAILABILITY OF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS UNKNOWN. FOR VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) LOT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED. THERAPY WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS DISCONTINUED ON (B)(6) 2023. THE OUTCOME OF DISSEMINATED INTRAVASCULAR COAGULATION WAS CONSIDERED AS NOT RECOVERED (REPORTED AS "PATIENT WAS IN DIC"). THE REPORTER'S CAUSALITY ASSESSMENT WAS NOT PROVIDED. UPON INTERNAL REVIEW, THE EVENT OF DISSEMINATED INTRAVASCULAR COAGULATION WAS DETERMINED TO BE MEDICALLY SIGNIFICANT. 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. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. FDA CODE: (HEALTH EFFECTS - HEALTH IMPACT PER ANNEX F): 4641 UNEXPECTED MEDICAL INTERVENTION (PATIENT REQUIRED AN UNFORESEEN MEDICAL INTERVENTION, EXCLUDING SURGERY, WHICH WAS NOT ON THE ORIGINAL TREATMENT PLAN.) FDA CODE: (HEALTH EFFECTS - HEALTH IMPACT PER ANNEX F): 4643 BLOOD TRANSFUSION (PATIENT REQUIRED AN INFUSION OF WHOLE BLOOD OR A BLOOD COMPONENT DIRECTLY INTO THE BLOODSTREAM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227012 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| O