BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATRISTEM SURGICAL MATRIX PSMT

    MDR report key: 3780707 · Received April 21, 2014

    Report

    Report Number
    3005920706-2014-00004
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 24, 2014
    Manufacturer
    ACELL INC.
    Product Code
    FTM
    PMA / PMN Number
    K041140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY CONDUCTED ON DISCOVERY. NO SUBSTANTIAL DEVIATION WAS IDENTIFIED AND ALL RECORDS PURPORT THE PRODUCT WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL, AND MANUFACTURER OPERATING PROCEDURES. THERE WAS NO REPORT OF DEVICE FAILURE AT THE TIME OF SURGERY.

    Description of Event or Problem · 1

    MATRISTEM SURGICAL MESH DEVICE WAS USED AS AN ONLAY FOR A VENTRAL HERNIA PROCEDURE IN (B)(6) 2013. THE PT DEVELOPED A CHRONIC SEROMA AND ON MARCH 21, 2014 THE DEVICE WAS FOUND TO BE ENCAPSULATED AND THE DEVICE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241400 MATRISTEM SURGICAL MATRIX PSMT SURGICAL MESH FTM ACELL INC. OM818-802

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R CHEMOTHERAPY