BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROVOX BRUSH

    MDR report key: 21176094 · Received January 17, 2025

    Report

    Report Number
    8032044-2025-00001
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 30, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ATOS MEDICAL AB
    Product Code
    LRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: IT IS LIKELY THAT THE SAFETY TIP HAVE COME OFF THE BRUSH HEAD DUE TO NORMAL WEAR AND TEAR. THE RECOMMENDED USAGE TIME FOR A PROVOX BRUSH IS 1 MONTH. INFORM THE USER TO READ AND FOLLOW THE IFU, NOT TO BEND THE BRUSH HEAD AND INSPECT THE BRUSH BEFORE EACH USE. INVESTIGATION: THIS IS A THEORETICAL INVESTIGATION; SAMPLE WAS NOT AVAILABLE. FOLLOW UP QUESTIONS: IS IT POSSIBLE TO FIND OUT THE PROVOX VEGA KITS' LOT NUMBER? (TO TRACK PROVOX BRUSH'S LOT NUMBER SINCE THE BRUSH IS INCLUDED IN THE PROVOX VEGA VOICE PROSTHESIS) ANSWER: 2402331 IS THE LOT NUMBER FOR THE PROVOX VEGA. IF THE BRUSH WAS BENT IN THE METAL WIRE PART OR IN THE HANDLE PART? ANSWER: NOT BENT, BUT THE BRISTLES ARE WORN. FOR HOW LONG WAS THE BRUSH USED? ANSWER: THE BRUSH WAS USED FOR 4 MONTHS, JUST THE ONE BRUSH. IS THE PATIENT OK NOW? ANSWER: YES, THE PATIENT IS DOING WONDERFUL SINCE. ROOT CAUSE: NOT IDENTIFIED, PROBABLE USER ERROR. DISCUSSION: THE BRUSH HEAD OF THE PROVOX BRUSH CONSISTS OF NYLON FILAMENTS AS BRISTLES, TWISTED METAL WIRE (DIAMETER: 0.65MM, STAINLESS STEEL) THAT IS INJECTION MOLDED INSIDE A PP PLASTIC SHAFT OR HANDLE, AND A PP-PLASTIC TIP ON TOP OF THE BRUSH HEAD. ALL BATCHES ARE SAMPLED AT PRODUCTION AND SAMPLES ARE PULL TESTED. ACCORDING TO THE IFU THE PROVOX BRUSH SHOULD NEVER BE BENT IN THE WIRE, ONLY THE BRUSH SHAFT SHOULD BE BENT. CLEAN THE BRUSH ACCORDING TO INSTRUCTIONS IN THE IFU USING DRINKING WATER. DO NOT USE A WORN BRUSH. RECOMMENDED TIME OF USAGE IS 1 MONTH. ALWAYS INSPECT THE BRUSH BEFORE EACH USE. INTERNAL INVESTIGATION: THE PROVOX BRUSH CAME FROM PROVOX VEGA REF 8272 WITH LOT NUMBER: 2402331 WHICH CONTAINS PROVOX BRUSH LONG REF 84060 (1 PC) WITH LOT NUMBER: 23.502.02. RISK ASSESSMENT: RH009-HAZ, H01: PROSTHESIS PULLED OUT OR DAMAGED, PROVOX BRUSH DAMAGED OR BROKEN LEADING TO PROSTHESIS OR PARTS OF PROSTHESIS OR BRUSH IN TRACHEA, OR BRUSH OR PARTS OF IT STUCK IN VOICE PROSTHESIS: MEDICAL INTERVENTION (X-RAY/BRONCHOSCOPY, OR SIMILAR) NECESSARY, AND/OR RETRIEVED BY CLINICIAN (6), OR RETRIEVED BY PATIENT (4), IN MOST CASES COUGHED UP (2). TRENDING: DATA DOES NOT INDICATE ANY UNFAVORABLE TRENDS.

    Description of Event or Problem · 0

    THE BLUE SAFETY TIP FROM PROVOX BRUSH DISLODGED AND FELL INTO THE PATIENT'S AIRWAY. THE CLINICIAN REPORTED THAT BRONCHOSCOPY WAS NECESSARY AS MEDICAL INTERVENTION FOLLOWING THIS EVENT TO RETRIEVE THE SAFETY TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006388 PROVOX BRUSH AIRWAY DEVICE CLEANING UTENSIL, INVASIVE LRC ATOS MEDICAL AB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention