BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULAN

    MDR report key: 22588402 · Received July 24, 2025

    Report

    Report Number
    9617083-2025-01170
    Event Type
    Injury
    Date Received
    July 24, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON 14TH JULY 2025, BIOCOMPOSITES LTD RECEIVED AN EMAIL COMPLAINT FROM A CUSTOMER THAT THEY HAVE OBSERVED CASES OF HYPERCALCAEMIA IN PATIENTS IMPLANTED WITH STIMULANT. THEY DID NOT PROVIDE ANY FURTHER INFORMATION RELATING TO THE INCIDENTS OR THE SPECIFIC PRODUCT USED AND A REQUEST FOR FURTHER INFORMATION HAS BEEN MADE TO THE CUSTOMER.

    Description of Event or Problem · 0

    ON (B)(6) 2025, BIOCOMPOSITES LTD RECEIVED AN EMAIL COMPLAINT FROM A CUSTOMER THAT THEY HAVE OBSERVED CASES OF HYPERCALCAEMIA IN PATIENTS IMPLANTED WITH STIMULAN. THEY DID NOT PROVIDE ANY FURTHER INFORMATION RELATING TO THE INCIDENTS OR THE SPECIFIC PRODUCT USED AND A REQUEST FOR FURTHER INFORMATION HAS BEEN MADE TO THE CUSTOMER. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION, NONE HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188116 STIMULAN STIMULAN MQV BIOCOMPOSITES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention