BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATTICE

    MDR report key: 2190751 · Received August 4, 2011

    Report

    Report Number
    1000306051-2011-00019
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 4, 2011
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INFORMATION REPORTED TO LIFECELL. REVIEW OF THE DEVICE HISTORY RECORDS. REVIEW OF THE LIFECELL COMPLAINT SYSTEM FOR ANY SIMILAR COMPLAINTS REPORTED TO LIFECELL AGAINST THIS LOT. REVIEW OF THE DEVICE HISTORY RECORD RESULTED IN NO REMARKABLE FINDINGS, WITH NO DEVIATIONS RELATED TO THE NATURE OF THIS COMPLAINT. (B)(4). BASED ON THE INFORMATION REPORTED, THIS EVENT WAS EVALUATED AS A MALFUNCTION, MULTIPLE SUTURES PULL THROUGH- INTRA-OPERATIVE, WITH NO SERIOUS INJURY. LIFECELL WAS UNABLE TO CLEARLY DETERMINE NUMBER OF SUTURES THAT PULLED THROUGH THE DEVICE. THEREFORE, LIFECELL IS FILING THIS FDA REPORT SINCE THE EVENT MAY HAVE THE POTENTIAL TO CAUSE A PROLONGATION OF THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL THAT MULTIPLE SUTURES PULL THROUGH OCCURRED DURING ABDOMINAL HERNIA REPAIR, WITH AN UNCLEAR DETERMINATION OF THE NUMBER OF SUTURES INVOLVED. THE DEVICE WAS REPAIRED WITH SIMILAR DEVICE. LIFECELL WAS INFORMED THAT PATIENT WAS DISCHARGED FROM HOSPITAL WITHOUT COMPLICATION AND IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 1525002 S10720-157

    Patients

    Seq Age Sex Outcome Treatment
    1