BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 5569856 · Received April 12, 2016

    Report

    Report Number
    3010187263-2016-00003
    Event Type
    Injury
    Date Received
    April 12, 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 THIS EVENT. THE CLINICAL EXPERT CONFIRMED OUR CONCLUSION THAT THERE IS NO REASON TO BELIEVE THAT THE INFECTIONS WERE CAUSED BY THE TIGR PRODUCT. RISK FACTORS FOR THIS PATIENT ARE PRIOR RADIOTHERAPY, INSULIN TREATED DIABETES AND LARGE BREAST IMPLANTS (560 CC) AND THE FACT THAT THE PATIENT IS A SMOKER. THESE RISK FACTORS COMBINED IS CONSIDERED TO RESULT IN A HIGH RISK FOR COMPLICATIONS WHEN PERFORMING IMMEDIATE BREAST RECONSTRUCTION REGARDLESS IF A SURGICAL MESH IS USED OR WHAT KIND OF SURGICAL MESH THAT IS USED. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT HAD RECURRENT BREAST CANCER ON THE LEFT SIDE. THE PATIENT HAS A HISTORY OF BREAST CONSERVATION SURGERY, RADIATION AND CHEMOTHERAPY. THE PATIENT UNDERWENT MASTECTOPY ON BOTH SIDES AND BREAST RECONSTRUCTION WITH IMPLANTS (560 CC) AND TIGR MATRIX SURGICAL MESH FOR REINFORCEMENT OF SOFT TISSUE (B)(6) 2016. THE PATIENT THEN DEVELOPED WOUND INFECTIONS ON BOTH SIDES AND THE SURGEON DECIDED TO CHANGE THE IMPLANTS AND REMOVE TIGR ON BOTH BREASTS. THE DATE OF THE EXPLANTATION (EVENT DATE) IS UNKNOWN BUT IT WAS NO LATER THAN THE REPORTING DATE (B)(6)2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227438 TIGR MATRIX SURGICAL MESH POLYMERIC SURGICAL MESH, BIODEGRADABLE FTL NOVUS SCIENTIFIC AB NSTM2030 302011018-04

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention POLYTECH BREAST IMPLANTS