BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JADA SYSTEM

    MDR report key: 14209508 · Received April 26, 2022

    Report

    Report Number
    3017425145-2022-00069
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 26, 2022
    Manufacturer
    ALYDIA HEALTH
    Product Code
    OQY
    UDI-DI
    00850017882003
    PMA / PMN Number
    K201199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE OVERALL INFORMATION CURRENTLY AVAILABLE FOR THIS REPORT, A POSSIBLE CONTRIBUTING OR CAUSAL ROLE OF THE JADA SYSTEM FOR THE NEED OF ESCALATING TREATMENT (HYSTERECTOMY) TO PRECLUDE PERMANENT BODY DAMAGE/IMPAIRMENT CANNOT BE EXCLUDED. PER THE JADA SYSTEM IFU, "SIGNS OF PATIENT DETERIORATION OR FAILURE TO IMPROVE INDICATE THE NEED FOR REASSESSMENT AND POSSIBLY MORE AGGRESSIVE TREATMENT AND MANAGEMENT OF POSTPARTUM HEMORRHAGE (PPH)/ABNORMAL POSTPARTUM UTERINE BLEEDING.", "EVALUATE FOR LACERATIONS, RETAINED PRODUCTS OF CONCEPTION, OR OTHER CAUSES OF BLEEDING PRIOR TO USING JADA." AND "JADA IS NOT A SUBSTITUTE FOR SURGICAL MANAGEMENT AND FLUID RESUSCITATION OF LIFE-THREATENING PPH/ABNORMAL POSTPARTUM UTERINE BLEEDING." OUT OF AN ABUNDANCE OF CAUTION, THE COMPANY WILL REPORT THIS CASE AS A SERIOUS INJURY MDR.

    Description of Event or Problem · 0

    ALYDIA HEALTH EMPLOYEE HAD A CONVERSATION WITH A HEALTH CARE PROVIDER (HCP) ON (B)(6) 2022 THAT REPORTED JADA DID NOT STOP THE POSTPARTUM HEMORRHAGE (PPH) AND STATED "THE PATIENT HAD A HYSTERECTOMY TO STOP THE PPH." THE EVENT DATE FOR THIS CASE WAS (B)(6) 2022. THE LIMITED INFORMATION PROVIDED FOR THIS EVENT WAS RECEIVED FROM A PHONE CALL AND A FOLLOW UP EMAIL. THIS PATIENT WAS DESCRIBED AS "AR" AND SHE HAD A REPEAT CESAREAN SECTION, HER THIRD. THE PATIENT WAS DILATED TO THREE CM, THE JADA WAS PLACED, AND IT WAS DESCRIBED AS FUNCTIONING "FINE." THE JADA WAS IN PLACE FOR 30 MINUTES, BUT THE PPH CONTINUED, AND THE PATIENT'S VITAL SIGNS WERE "NOT STABLE", SO THE HCP MADE THE DECISION TO ADVANCE HER CARE TO HYSTERECTOMY. THE HCP "THINKS IT WAS AN ANATOMICAL ISSUE NOT THE DEVICE. THE PATIENT HAD FRIABLE TISSUE ALSO." THE SITE REPORTS THAT THEY DISCARDED THE DEVICE AND DID NOT RECORD A LOT NUMBER FOR THIS JADA, A GOOD FAITH EFFORT HAS BEEN MADE TO OBTAIN THIS INFORMATION. THE HCP DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION ON THIS PATIENT, CASE, OR USE OF THE JADA DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513451 JADA SYSTEM INTRAUTERINE VACUUM CONTRACTION SYSTEM OQY ALYDIA HEALTH JADA - 1001 00850017882003

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability