BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULAN® RAPID CURE

    MDR report key: 21066743 · Received January 3, 2025

    Report

    Report Number
    21066743
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    November 25, 2024
    Report Date
    December 11, 2024
    Manufacturer
    BIOCOMPOSITES, INC.
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THIS WAS A NEAR MISS EVENT, AND IT DID NOT REACH THE PATIENT OR CAUSE PATIENT HARM. WHEN OPENING STIMULANT 5CC IMPLANT FOR ANTIBIOTIC BEADS, SCRUB TECH FOUND A HAIR IN THE STIMULANT POWDER. POWDER WAS NOT USED FOR PATIENT AND PULLED OFF OF STERILE FIELD FOR REPORTING. STIMULAN 5CC (REF# 620-005, LOT # SR240315, EXP: 2027-03-31). STAFF DID NOT NOTE A SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463324 STIMULAN® RAPID CURE FILLER, BONE VOID, CALCIUM COMPOUND MQV BIOCOMPOSITES, INC. 620-005 SR240315

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male