BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRATTICE

    MDR report key: 1680700 · Received May 12, 2010

    Report

    Report Number
    1000306051-2010-00004
    Event Type
    Death
    Date Received
    May 12, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 10, 2010
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: - REVIEW OF THE DEVICE HISTORY RECORDS - QUERY OF LIFECELL COMPLAINT SYSTEM FOR ANY ISSUES OR OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST DEVICES DISTRIBUTED FROM LOT S10615 ) - REVIEW OF THE DEVICE HISTORY RECORDS RESULTED IN NO REMARKABLE FINDINGS - TO DATE, OF THE 201 DEVICES DISTRIBUTED FROM LOT S10615, 69 DEVICES WERE REPORTED AS IMPLANTED, WITH NO ISSUES OR OTHER COMPLAINTS REPORTED TO LIFECELL BASED ON THE INFORMATION REPORTED AND INTERNAL INVESTIGATION INTO COMPLAINT RELATED LOT, THE EVENT WAS EVALUATED AS UNRELATED TO THE DEVICE. LIFECELL REQUESTED ADDITIONAL INFORMATION FROM (B) (6) MEDICAL CENTER. AS OF TO DAY, NO INFORMATION WAS PROVIDED. DUE TO NATURE OF THE EVENT, DEATH, AND LACK OF THE INFORMATION AVAILABLE, LIFECELL REPORTS THIS EVENT TO FDA. LIFECELL WILL FILE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL, AS FOLLOWS: - ON (B) (6) 2010, THE DEVICE WAS IMPLANTED FOR REPAIR OF A LARGE INCISIONAL HERNIA - FIVE DAYS POST-OPERATIVELY, THE PATIENT, WITH A HISTORY OF COPD, COUGHED AND THE DEVICE SPLIT - SURGEON EXPLANTED A PART OF THE DEVICE AND REPAIRED WITH A DIFFERENT SURGICAL MESH LIFECELL WAS INFORMED THAT THE PATIENT HAS EXPIRED (DATE AND CAUSE OF DEATH ARE UNKNOWN, AT THIS TIME)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 1620002 S10615-112

    Patients

    Seq Age Sex Outcome Treatment
    1 Death