BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 14366513 · Received May 11, 2022

    Report

    Report Number
    3017425145-2022-00087
    Event Type
    Injury
    Date Received
    May 11, 2022
    Report Date
    May 11, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 COMPLAINANT REPORTED THAT THE DEVICE WORKED APPROPRIATELY. THE DEVICE IS ASSEMBLED ACCORDING TO SPECIFICATIONS. IN PROCESS AND FINISHED PRODUCT TESTED ARE PERFORMED AND APPROVED PRIOR TO RELEASE.

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT ORIGINATING FROM UNITED STATES WAS RECEIVED FROM A PHYSICIAN AND A NURSE VIA SALES REPRESENTATIVE, REFERRING TO A FEMALE PATIENT OF UNKNOWN AGE. THIS REPORT CONCERNS 1 PATIENT AND 1 DEVICE. THE PATIENT HAD A KNOWN PLACENTA PREVIA. ON AN UNKNOWN DATE, THE PATIENT WAS INSERTED WITH VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM). THE NURSE STATED THAT, THE VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS INSERTED AND WORKED CORRECTLY, WITH EXCELLENT TONE AND MINIMAL BLOOD IN THE TUBING, AND THEY DECIDED TO TAKE THE PATIENT TO INTERVENTIONAL RADIOLOGY (IR) FOR UTERINE ARTERY EMBOLIZATION (UAE) AS A PRECAUTION. IT WAS ALSO REPORTED THAT THEY DECIDED TO TAKE THE PATIENT TO INTERVENTIONAL RADIOLOGY (IR) FOR UTERINE ARTERY EMBOLIZATION (UAE) AS A PRECAUTION (UTERINE ARTERY EMBOLIZATION). THE LOT NUMBER FOR VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) WAS 1070804, AND IT WAS UNKNOWN IF THE DEVICE HAS BEEN RETAINED. THERE WAS NO INFORMATION ON ESTIMATED BLOOD LOSS (EBL)/ QUANTITATIVE BLOOD LOSS (QBL) PRIOR TO OR AFTER THE DEVICE USE, NO INTERVENTIONS PRIOR TO THE DEVICE USE REPORTED. ADDITIONALLY, IT WAS REPORTED THAT AFTER VACUUM-INDUCED HEMORRHAGE CONTROL SYSTEM (JADA SYSTEM) PLACEMENT, THE PROVIDER WONDERED IF IT MIGHT HAVE BEEN PLACENTA ACCRETA (AS THE PATIENT WAS KNOWN FOR PLACENTA PREVIA), HOWEVER THE PATHOLOGY DID NOT BACK. IT WAS REPORTED THAT, WHILE THERE WAS MINIMAL BLOOD COMING OUT AFTER VACUUM ON, A NURSE FELT THAT THE UTERUS WAS RISING. SHE SAID THAT, WHEN VACUUM WAS TURNED OFF AND CERVICAL SEAL DEFLATED, THERE WAS ABOUT A LITER OF BLOOD THAT CAME OUT IMMEDIATELY. MEDICAL DEVICE REPORTING CRITERIA: SERIOUS INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2382615 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female