BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATTICE

    MDR report key: 2202753 · Received August 11, 2011

    Report

    Report Number
    1000306051-2011-00021
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 11, 2011
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: REVIEW OF INFORMATION REPORTED TO LIFECELL. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE DEVICE REVIEW OF THE LIFECELL COMPLAINT SYSTEM FOR ANY SIMILAR COMPLAINTS REPORTED TO LIFECELL AGAINST THIS LOT. RESULTS OF EVALUATION: REVIEW OF THE DEVICE HISTORY RECORD RESULTED IN NO REMARKABLE FINDINGS, WITH NO DEVIATIONS RELATED TO THE NATURE OF THIS COMPLAINT. TO DATE, (B)(4) DEVICES FROM THIS LOT WERE DISTRIBUTED, INCLUDING 14 DEVICES THAT WERE IMPLANTED, WITH ONE OTHER SIMILAR COMPLAINT REPORTED TO LIFECELL BY SAME THE FACILITY. CONCLUSION: BASED ON INTERNAL INVESTIGATION, THE DEVICE MET QC RELEASE CRITERIA INCLUDING MECHANICAL TESTING

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A HERNIA REPAIR OF A LARGE ABDOMINAL WALL AND FLANK DEFECT INCLUDING RESECTION OF THE ILIAC CREST. THE DEVICE TORE DURING IMPLANTATION OF THE DEVICE. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 2025002 S10919-013

    Patients

    Seq Age Sex Outcome Treatment
    1