BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMATRIX, 500 MG

    MDR report key: 20368845 · Received October 4, 2024

    Report

    Report Number
    3005920706-2024-00008
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 6, 2024
    Report Date
    February 21, 2025
    Manufacturer
    INTEGRA - ACELL(COLUMBIA)
    Product Code
    KGN
    UDI-DI
    00386190001189
    PMA / PMN Number
    K172399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MICROMATRIX (ID (B)(6)) WAS NOT RETURNED FOR EVALUATION, BUT A PHOTO WAS PROVIDED, HOWEVER, IT IS UNCLEAR WHERE THE BLACK PLASTIC SUBSTANCE ORIGINATED FROM. DEVICE HISTORY RECORD (DHR) - THE ATTACHED LOT RELEASE TESTING BATCH RECORD FOR LOT NO 040297 DEMONSTRATE THAT NO ANOMALIES OR NONCONFORMANCES OCCURRED DURING THE MANUFACTURE OR PACKAGING OF THE DEVICE. ROOT CAUSE ANALYSIS - SINCE NO DEVICE RETURN IS AVAILABLE, THE ROOT CAUSE IS INDETERMINATE. POTENTIAL ROOT CAUSES FOR THE PLASTIC SUBSTANCE ARE THAT IT WAS ALREADY PRESENT IN THE TRAY SHOWN IN THE IMAGES, THAT IT WAS INTRODUCED DURING THE OPENING OF THE VIAL OR INTRODUCED DURING THE MICROMATRIX MANUFACTURING PROCESSES.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED "PLASTIC" SUBSTANCE WAS FOUND WHEN A MICROMATRIX VIAL WAS EMPTIED INTO A STERILE FIELD. PRODUCT WAS STORED IN A RFID CABINET THAT HAS INTERNAL TEMPERATURE MONITORING. DEVICE WAS WITHIN RANGE DURING STORAGE IN THE FACILITY. NO TOOLS WERE IN CONTACT WITH THE VIAL. NO PATIENT CONTACT/INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442991 MICROMATRIX, 500 MG WOUND PARTICULATE DEVICES KGN INTEGRA - ACELL(COLUMBIA) 040297 00386190001189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown