BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 5253879 · Received November 30, 2015

    Report

    Report Number
    3010187263-2015-00005
    Event Type
    Injury
    Date Received
    November 30, 2015
    Date of Event
    November 6, 2015
    Report Date
    November 24, 2015
    Manufacturer
    NOVUS SCIENTIFC AB
    Product Code
    FTL
    UDI-DI
    07332999000024
    PMA / PMN Number
    K092224
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVUS SCIENTIFIC HAS NEVER EVER RECEIVED ANY COMPLAINT REGARDING AN AUTOIMMUNE DISEASE. POLYMERS USED IN THE PRODUCT ARE WELL KNOWN AND HAVE BEEN USED IN DIFFERENT IMPLANTABLE MEDICAL DEVICES FOR DECADES. A NUMBER OF LITERATURE SEARCHES WERE PERFORMED IN PUBMED TO STUDY IF THERE EXISTS ANY LITERATURE THAT INDICATES THAT THE POLYMERS USED IN THE PRODUCT CAN CAUSE AN AUTOIMMUNE DISEASE. TOTALLY 59 ARTICLES WERE REVIEWED AND NO ARTICLE SUGGESTED THAT THE POLYMERS COULD CAUSE AN AUTOIMMUNE DISEASE. DEVICE IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    DURING THE AUTUMN OF 2014, THE PATIENT REPORTED INCREASING IN FATIGUE, MUSCLE PAIN, LOCALIZED STIFFNESS AND THICKENING OF THE SKIN ON THE BODY AND PROXIMAL TO THE EXTREMITIES. FURTHERMORE, THE PATIENT REPORTED TINGLING SENSATIONS IN THE LEFT UPPER LIMB AND THE LEFT SIDE OF THE FACE. FINALLY, SHE HAD DYSPNEA AND LIGHT CHEST TIGHTNESS. DERMATOLOGISTS / RHEUMATOLOGISTS HAVE DIAGNOSED STEPWISE AND NOT GENERALIZED SCLERODERMA (MORPHEA). SINCE A PET-CT SCAN HAS SHOWN A REACTION IN THE ABDOMINAL WALL IN RELATION TO THE IMPLANTED MESH, ONE HAS SUSPECTED AN IMMUNOLOGICAL REACTION TO MESH MATERIAL. THE PATIENT HAS BEEN TREATED WITH IMMUNOSUPPRESSIVE THERAPY AND UVA LIGHT THERAPY WITH REASONABLE EFFECT ON THE SYMPTOMS. THE PATIENT HAS ALSO BEEN DIAGNOSED A SLIGHT BRONCHIAL ASTHMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786129 TIGR MATRIX SURGICAL MESH POLYMERIC SURGICAL MESH, BIODEGRADABLE FTL NOVUS SCIENTIFC AB NSTM2030 302010413 07332999000024

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention