BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 16693335 · Received April 6, 2023

    Report

    Report Number
    1000306051-2023-00087
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    July 3, 2014
    Report Date
    April 6, 2023
    Manufacturer
    LIFECELL
    Product Code
    FTM
    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 VALID 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 64 YEAR OLD PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2014. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED TWO STRATTICE MESHES; LOT # S11253-091; REF # 3030002 MESH AND LOT # S1273-014 REF # 3030002. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, FOR A REVISION AND REMOVAL SURGERY. THIS RECORD IS ASSOCIATED WITH THE SECOND DEVICE IMPLANTED, S1273-014 ; REF # 3030002; HOWEVER THIS IS NOT A VALID LOT NUMBER AND HAS BEEN DEFAULTED TO UNKNOWN. THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR # 1000306051-2023-00083 (ABBVIE COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868831 UNKNOWN STRATTICE MESH, SURGICAL FTM LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Required Intervention