BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIGR MATRIX SURGICAL MESH

    MDR report key: 4755221 · Received April 29, 2015

    Report

    Report Number
    3010187263-2015-00004
    Event Type
    Injury
    Date Received
    April 29, 2015
    Date of Event
    March 31, 2015
    Report Date
    April 28, 2015
    Manufacturer
    NOVUS SCIENTIFIC AB
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE MFR (NOVUS SCIENTIFIC) THAT A PHYSICIAN WHO USED THE DEVICE ("TIGR" OR TIGR MATRIX SURGICAL MESH) FOR BREAST RECONSTRUCTION EXPERIENCED, DURING A PT FOLLOW UP VISIT, THAT THE PT'S BREAST WAS A BIT STIFF, SIMILAR TO CAPSULAR CONTRACTURE. THE PHYSICIAN CLAIMS THAT TIGR FORMED A THICK (STIFF) SCAR PLATE THAT HE THINKS MAY POTENTIALLY BE THE CAUSE OF CAPSULAR CONTRACTURE. HE ALSO CLAIMS THAT THE MESH DID NOT EXPAND AS PREDICTED DURING THE EXPANSION PHASE. THE MESH WAS EVENTUALLY EXPLANTED. THE PT IS NOW STABLE AND NO FURTHER ISSUES OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282867 TIGR MATRIX SURGICAL MESH FTL NOVUS SCIENTIFIC AB NSTM2030 302010513

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK