BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 16461556 · Received March 1, 2023

    Report

    Report Number
    1000306051-2023-00051
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    March 21, 2014
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE LOT ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE AN INTERNAL INVESTIGATION INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, INCLUDING NO IDENTIFICATION OF THE LOT NUMBER, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE EVENT AND THE STRATTICE COULD NOT BE DETERMINED. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. 76. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH DURING BOTH THE FEBRUARY AND OCTOBER 2013 SURGERIES. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT MARCH 21, 2014, FOR A REVISION SURGERY, RESULTING IN PLAINTIFF¿S TWO STRATTICE MESHES BEING REMOVED. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 1000306051-2023-00052 (ALLERGAN COMPLAINT #: (B)(4)). THIS MDR IS BEING SUBMITTED FOR THE FIRST DEVICE IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143116 UNKNOWN STRATTICE MESH, SURGICAL FTM LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Required Intervention NO INFORMATION REPORTED