BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MICROMATRIX

    MDR report key: 14685093 · Received June 14, 2022

    Report

    Report Number
    3005920706-2022-00007
    Event Type
    Injury
    Date Received
    June 14, 2022
    Report Date
    July 7, 2022
    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

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H10. THE MICROMATRIX WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3005920706-2022-00008. A PHYSICIAN REPORTED SLOUGHING OF SKIN GRAFT TWICE AFTER MICROMATRIX USAGE, SEVERAL WEEKS AFTER FIRST USE, THEN SEVERAL MONTHS AFTER INITIAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER SEVERAL ATTEMPTS.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789310 UNKNOWN MICROMATRIX MICROMATRIX KGN INTEGRA - ACELL(COLUMBIA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown