BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULAN RAPID CURE

    MDR report key: 19002623 · Received March 28, 2024

    Report

    Report Number
    MW5153345
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    November 13, 2023
    Report Date
    March 26, 2024
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HYPERCALCEMIA WITH LEVEL UP TO 10.8 FOLLOWING PLACEMENT OF DEVICE. DEVICE IS STIMULAN #LOG1494849 (BIOCOMPOSITES) ON (B)(6) 2023. DURING ORTHOPEDIC SURGERY, 25CC OF BEADS WERE PLACED DURING A R OPEN SHOULDER ARTHROTOMY, IRRIGATION AND DEBRIDEMENT FOR A SHOULDER ABSCESS. ON POST OPERATIVE DAY#1, THE PATIENT'S CALCIUM BECAME ELEVATED. IT WAS NOT PREVIOUSLY ELEVATED. PATIENT'S DISCHARGE WAS DELAYED BY 4 DAYS DUE TO RESULTANT HYPERCALCEMIA. PATIENT WAS RE-CHALLENGED ON A SECOND SURGERY WITH PLACEMENT OF ADDITIONAL STIMULAN #LOG1445393 BEADS (10 ML) ON (B)(6) 2024. AGAIN ON POST OPERATIVE DAY#1, THE PATIENT'S CALCIUM BECAME ELEVATED. IT WAS NOT ELEVATED BETWEEN POST OPERATIVE DAY#5 OF THE PRIOR SURGERY AND THE NEW SURGERY. AFTER THIS, THE CALCIUM LEVEL REACHED 12.4 AND PERSISTED AS ELEVATED FOR 12 DAYS DESPITE CALCITONIN. REFERENCE REPORT: MW5153346. HYPERCALCEMIA DEVELOPED DAY AFTER SURGERY AND PERSISTED FOR 4 DAYS ON FIRST. AFTER RE-CHALLENGE, HYPERCALCEMIA PERSISTED FOR 12 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567103 STIMULAN RAPID CURE FILLER, BONE VOID, CALCIUM COMPOUND MQV BIOCOMPOSITES LTD. SR230602 LOG1445393

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| O