BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROMATRIX 500 MG

    MDR report key: 12719606 · Received October 29, 2021

    Report

    Report Number
    3005920706-2021-00004
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 6, 2021
    Report Date
    November 22, 2021
    Manufacturer
    INTEGRA - ACELL(COLUMBIA)
    Product Code
    KGN
    PMA / PMN Number
    K172399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MM0500 MICROMATRIX WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - NO ANOMALY SPECIFICALLY RELATED TO THE COMPLIANT ALLEGATION IS IDENTIFIED. FAILURE ANALYSIS - SUBSEQUENT TO THE INFORMATION PROVIDED BY THE COMPLAINANT COUPLED WITH THE RESULTS OF INTEGRA'S INVESTIGATION OF THE DEVICE HISTORY RECORD INCLUDING PRODUCT LABELING, IT HAS BEEN CONCLUDED THAT MM0500, LOT 017093 WAS MANUFACTURED IN DIRECT COMPLIANCE WITH THE DMR AS WELL AS THE EXPIRY DATE VERIFIED AS BEING CORRECT. THE ONLY FAILURE IDENTIFIED WAS HCP USER ERROR BY FAILURE TO VERIFY THE EXPIRY DATE PRIOR TO USE. USER INADVERTENTLY USED AN EXPIRED DEVICE. EXPIRATION DATE WAS CORRECTLY PRINTED ON THE DEVICE LABELING. DEVICE IS WITHIN SPECIFICATION AND DID NOT FAIL. THIS IS USER ERROR. NO ANOMALY SPECIFICALLY RELATED TO THE COMPLAINT ALLEGATION IS IDENTIFIED.

    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

    A SALES REPRESENTATIVE REPORTED AN EXPIRED MICROMATRIX WAS USED DURING A CASE. THE DOCTOR ASKED FOR MICROMATRIX AND REPRESENTATIVE MISTAKENLY REMOVED THE EXPIRED PRODUCT FROM BACKPACK AND HANDED PRODUCT TO NURSE IN THE ROOM, AS IS STANDARD OPERATING ROOM PROCEDURE. SCRUB TECH OPENED STERILE PRODUCT AND PASSED PRODUCT TO DOCTOR. POST-OPERATIVE REVIEW REVEALED EXPIRED PRODUCT WAS UTILIZED IN CASE. REPRESENTATIVE, SCRUB TECH AND NURSE MANGER ALERTED DOCTOR. DOCTOR SPOKE WITH HOSPITAL TO INFORM THAT THIS PRODUCT WAS NOT IMPLANTED INTO PATIENT OR SUTURED INTO WOUND---IT WAS SUPERFICIALLY SPRINKLED TOPICALLY ONTO FOOT WOUNDS. DOCTOR SPOKE WITH REPRESENTATIVE AND RELAYED THAT HE DOES NOT BELIEVE THIS WILL BE A DETRIMENT TO PATIENT AND WILL CONTINUE TO MONITOR SITUATION. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT IS STABLE AND HAS SEEN NO SIDE EFFECTS OR ADVERSE EFFECTS FROM PRODUCT. PRODUCT WAS PLACED TOPICALLY AND NO SIGNS OF INFECTION PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618686 MICROMATRIX 500 MG MICROMATRIX KGN INTEGRA - ACELL(COLUMBIA) 017093

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female