BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 5570531 · Received April 12, 2016

    Report

    Report Number
    3010187263-2016-00004
    Event Type
    Injury
    Date Received
    April 12, 2016
    Date of Event
    February 14, 2016
    Report Date
    April 12, 2016
    Manufacturer
    NOVUS SCIENTIFIC AB
    Product Code
    FTL
    PMA / PMN Number
    K092224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXPERIENCED BREAST SURGEON WAS CONSULTED AS A CLINICAL EXPERT IN THE INVESTIGATION OF THIS EVENT. THE CLINICAL EXPERT CONFIRMED OUR CONCLUSION THAT THERE IS NO REASON TO BELIEVE THAT THE CAUSE OF THE EVENT IS RELATED TO THE TIGR MATRIX PRODUCT. PRIOR RADIOTHERAPY, COPD AND LARGE BREAST IMPLANTS (620 CC) ARE RISK FACTORS FOR COMPLICATIONS IN IMMEDIATE RECONSTRUCTION. COMPLICATION WOULD HAVE HAPPENED IRRESPECTIVELY OF THE TYPE OF MATRIX USED AND WHETHER OR NOT A MATRIX WAS USED. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIOR BREAST CONSERVATION SURGERY, RADIOTHERAPY AND CHEMOTHERAPY AND HAD RECURRENT BREAST CANCER IN THE LEFT BREAST. THE PATIENT UNDERWENT MASTECTOMY AND IMPLANT RECONSTRUCTION (620 CC) WITH TIGR MATRIX SURGICAL MESH AS REINFORCEMENT OF SOFT TISSUE. THE PATIENT DEVELOPED INFLAMMATION AND SEROME FORMATION AND THE SURGEON PLANNED TO CHANGE THE IMPLANT AND REMOVE OF TIGR MATRIX (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225142 TIGR MATRIX SURGICAL MESH POLYMERIC SURGICAL MESH, BIODEGRADABLE FTL NOVUS SCIENTIFIC AB NSTM2030 302011018-08

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention PDS SUTURE