BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULAN

    MDR report key: 18674904 · Received February 9, 2024

    Report

    Report Number
    9617083-2024-00001
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    November 1, 2023
    Report Date
    February 9, 2024
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TWO EMAILS HAVE BEEN SENT TO THE REPORTING CA. ONE REQUESTING FURTHER PAITENT AND SUBMITTER DETAILS, THIS REQUEST WAS DENIED DUE TO NO PERMISSION TO SUBMIT DETAILS. SECOND EMAIL WAS REQUESTS FOR FURTHER INFORMATION ON THE DEVICE TYPES, SIZE AND ANY MXIING INFORMATION. NO FURTHER CORRESPONDENCE. NO FURTHER INVESITGATIONS CAN BE PLANNED. ON-GOING MONITORING OF INCIDENTS AND EVENTS SHALL BE CONDUCTED AS PER QUALITY SYSTEM

    Description of Event or Problem · 0

    THE NOTIFICATION FORM STATED: "STIMULAN BEADS INSERTED DURING OPERATIVE PROCEDURE, PATIENT SUBSEQUENTLY DEVELOPED SEVERE HYPERCALCEMIA WHICH REQUIRED EMERGENCY MANAGEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338631 STIMULAN STIMULAN MQV BIOCOMPOSITES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization