BEUDAMED
    FDA Adverse Event Death Summary report: N

    JADA SYSTEM

    MDR report key: 19883219 · Received August 1, 2024

    Report

    Report Number
    3002806821-2024-00069
    Event Type
    Death
    Date Received
    August 1, 2024
    Report Date
    August 1, 2024
    Manufacturer
    ORGANON & CO.
    Product Code
    OQY
    PMA / PMN Number
    510K K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    DEATH [DEATH]. CASE NARRATIVE: THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM NURSE AND CHIEF OBSTETRICIAN (OB) ON BEHALF OF A MEDICAL CENTER VIA A CLINICAL SALES EDUCATOR (CSE) REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THE PATIENT¿S MEDICAL HISTORY, CONCURRENT CONDITIONS, PAST DRUG REACTIONS/ALLERGIES AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. ON 17-MAY-2024, CSE STATED THAT AT A LUNCH, A NURSE MENTIONED THAT A PATIENT DIED AFTER POSTPARTUM HEMORRHAGE (DEATH). PER THE CSE, IT WAS MORE LIKE GOSSIP AND CSE DID NOT HAVE MUCH INFORMATION. CSE WENT TO LEADERSHIP THE SAME DAY REQUESTING ADDITIONAL INFORMATION, BUT LEADERSHIP STATED THEY DIDN'T KNOW ANYTHING. ON 21-MAY-2024 (ON THE DAY OF THE REPORT), THE CSE ATTENDED A MEETING AND SPOKE WITH THE CHIEF OB AFTERWARD. CHIEF OB ASKED THE CSE WHAT SHE HAD HEARD, AND THE CSE RELAYED THE ABOVE INFORMATION. CSE INQUIRED IF THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS IN PLACE. THE CHIEF OB WAS UNSURE IF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS IN PLACE AND STATED THAT IF THE PATIENT DIED IT WASN'T BECAUSE OF VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). CHIEF OB STATED HE COULD NOT DISCUSS THE EVENT GIVEN THAT THERE WAS A MATERNAL DEATH, AND INDICATED HE WOULD HAVE TO DISCUSS FURTHER WITH THE MEDICAL CENTER'S QUALITY, SAFETY, AND LEGAL DEPARTMENT TO SEE IF ADDITIONAL DETAILS COULD BE SHARED. THERE WAS NO CONFIRMATION OF THE USAGE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) IN THE PATIENT. THE DATE AND CAUSE OF DEATH WAS UNKNOWN. IT WAS UNKNOWN IF AUTOPSY WAS PERFORMED. THE CASE HAS BEEN CREATED IN OUR SAFETY DATABASE FOR VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) CONSERVATIVELY DUE TO LIMITED INFORMATION. THIS IS AN AMENDED REPORT: THE CASE NARRATIVE WAS REFRAMED TO CLEARLY INDICATE THE UNCERTAINTY OF DEVICE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) USE IN THIS CASE AS REPORTED BY THE CSE. THE CASE WAS REASSESSED AND REPORTED AS INCIDENT AS PER LIMITED INFORMATION. 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: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2025364 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ORGANON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death