BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIROMESH

    MDR report key: 5100892 · Received September 22, 2015

    Report

    Report Number
    3010894343-2015-00001
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 22, 2015
    Manufacturer
    MIROMATRIX MEDICAL INC.
    Product Code
    FTM
    PMA / PMN Number
    K134033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS COVERED THROUGH A THIRD PARTY AND WAS NOT DIRECTLY REPORTED TO THE COMPANY FROM THE HEALTH PRACTITIONER. THE COMPLAINANT WAS SOUGHT OUT FOR FURTHER DETAILS. THREE DIFFERENT MESH WERE USED ON THE PT. THE LOT NUMBERS WERE 1000135014, 1000131514, AND 1000130114. THE DEVICE HISTORY RECORDS WERE REVIEWED. ALL LOTS WERE RELEASED AGAINST APPROVED SPECIFICATIONS INCLUDING BUT NOT LIMITED TO APPROVED RADIATION DOSE, BACTERIAL ENDOTOXIN TESTING, AND REVIEW OF NON-CONFORMANCES AND PRODUCTION DEVIATIONS. ALL LOTS MET RADIATION DOSE AND ENDOTOXIN REQUIREMENTS. THERE WERE NO NON-CONFORMANCE OR DEVIATION REPORTS RELATED TO THE NATURE OF THE COMPLAINT. THERE HAVE BEEN NO COMPLAINTS OF THE REPORTED ISSUE FOR ANY OF THE LOT DISTRIBUTED TO THE CUSTOMER. THE CUSTOMER COULD NOT PINPOINT MIROMESH AS THE CAUSE OF SEPSIS. THE MIROMESH DID NOT APPEAR INFECTED. THE TISSUE EXPANDERS WERE EXPLANTED ALONG WITH THE MIROMESH. BASED ON THIS INVESTIGATION, IT IS UNLIKELY THAT MIROMESH WAS THE CAUSE OF THE SEPSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015 A PT WAS IMPLANTED WITH MIROMESH IN A BILATERAL BREAST RECONSTRUCTION PROCEDURE. ON (B)(6) 2015, THE PT PRESENTED WITH SEPSIS. CULTURES WERE TAKEN FROM THE PT AND SHOWED GROWTH OF SERRATIA MARCESCENS. ON (B)(6) 2015 MIROMESH WAS EXPLANTED FROM BOTH BREASTS. UPON EXPLANT, THE MIROMESH DID NOT APPEAR INFECTED. MIROMATRIX WAS INFORMED OF THIS EVENT ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625295 MIROMESH BIOLOGICAL MESH FTM MIROMATRIX MEDICAL INC. BLM-100-01-1020 1000135014

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R BLAKE DRAIN