BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 5569394 · Received April 12, 2016

    Report

    Report Number
    3010187263-2016-00002
    Event Type
    Injury
    Date Received
    April 12, 2016
    Date of Event
    January 26, 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 FOR THE INVESTIGATION OF THE EVENT. THE CLINICAL EXPERT CONFIRMED OUR CONCLUSION THAT THERE IS NO REASON TO BELIEVE THAT TIGR MATRIX CAUSED THE DERMIS NECROSIS ON THE RIGHT BREAST. THE MOST LIKELY CAUSE OF THE EVENT IS POOR BLOOD SUPPLY TO THE MASTECTOMY FLAPS. EARLIER CHEMOTHERAPY AND LARGE BREAST IMPLANTS (650 CC) ARE RISK FACTORS. DEVICE DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS DIAGNOSED WITH BREAST CANCER AND WAS TREATED WITH NEOADJUVANT CHEMOTHERAPY. BOTH BREASTS WENT THROUGH BILATERAL MASTECTOMY AND WERE RECONSTRUCTED (B)(6) 2015 WITH BREAST IMPLANTS OF SIZE 650 CC AND TIGR MATRIX SURGICAL MESH FOR REINFORCEMENT OF SOFT TISSUE. THE PATIENT DEVELOPED DERMIS NECROSIS ON THE RIGHT BREAST AND THE SURGEON DECIDED TO CHANGE THE IMPLANT AND REMOVE THE TIGR MESH (B)(6) 2016. THE PATIENT IS REPORTED TO BE IN A GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224844 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