BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 5569326 · Received April 12, 2016

    Report

    Report Number
    3010187263-2016-00001
    Event Type
    Injury
    Date Received
    April 12, 2016
    Date of Event
    February 23, 2016
    Report Date
    December 4, 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 PRODUCT CAUSED THE INFECTION. THE MOST LIKELY CAUSE OF THE INFECTION IS POOR BLOOD SUPPLY DUE TO EARLIER CANCER TREATMENT/BREAST SURGERY. DEVICE DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIOR MASTECTOMY AND BREAST IMPLANT ON THE LEFT BREAST AND AN AUGMENTATION MASTOPEXY AND BREAST IMPLANT ON THE RIGHT BREAST AS A RESULT OF BREAST CANCER IN THE LEFT BREAST. (B)(6) 2016 SHE HAD BOTH HER FORMER BREAST IMPLANTS CHANGED AND TIGR MATRIX SURGICAL MESH IMPLANTED AS REINFORCEMENT OF SOFT TISSUE. THE PATIENT DEVELOPED A WOUND INFECTION IN THE LEFT BREAST AND THE SURGEON DECIDED TO CHANGE THE BREAST IMPLANT AND REMOVE TIGR MATRIX (B)(6) 2016. THE PATIENT IS REPORTED TO BE IN A GOOD CONDITION AFTER THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227070 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 SILTEX ROUND HIGH PROFILE GEL IMPLANTS (MENTOR)