BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 4541616 · Received February 17, 2015

    Report

    Report Number
    3010187263-2015-00001
    Event Type
    Injury
    Date Received
    February 17, 2015
    Report Date
    February 17, 2015
    Manufacturer
    NOVUS SCIENTIFIC AB
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CONDITION IS FULLY RECOVERED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVUS SCIENTIFIC FROM THE (B)(6) DISTRIBUTOR THAT A PATIENT WHO HAD TIGR MATRIX IMPLANTED AS PART OF A BREAST RECONSTRUCTION HAD DEVELOPED INFECTION AND THAT THE MESH WAS EXPLANTED. THE IMPLANT OF TIGR SURGICAL MESH WAS DONE MID OF (B)(6), THE EXPLANT WAS DONE IN THE BEGINNING OF (B)(6), EXACT DATE IS UNKNOWN. THE PATIENT EVENT OCCURRED IN (B)(6). EXPLANT OF MESH AND TREATMENT WITH ANTIBIOTICS WAS NECESSARY. OUR DISTRIBUTOR STATES THAT THE CLINIC STAFF IN THE OPERATING ROOM INCORRECTLY ASSUMED THAT THE TYVEK POUCH (TIGR PACKAGING) WAS STERILE ON THE STERILE FIELD/TABLE. THE HANDLING MAY HAVE CONTRIBUTED TO THE EVENT. THE INSTRUCTIONS FOR USE CLEARLY EXPLAINS THAT ONLY THE INSIDE OF THE INNER PACKAGE IS CONSIDERED STERILE AND IN ADDITION A LABEL IS PLACED BETWEEN THE OUTER AND INNER PACKAGE TO REMIND USERS THAT THE OUTSIDE OF THE INNER BAG IS NOT STERILE. PATIENT IS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115032 TIGR MATRIX SURGICAL MESH POLYMERIC SURGICAL MESH, BIODEGRADABLE FTL 878.3300 FTL NOVUS SCIENTIFIC AB NSTM2030E 302011018

    Patients

    Seq Age Sex Outcome Treatment
    1 PDS LONG LASTING ABSORBABLE SUTURE, UNK FABRICATE