BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE

    MDR report key: 2213402 · Received August 16, 2011

    Report

    Report Number
    1000306051-2011-00027
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 16, 2011
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS. QUERY OF LIFECELL COMPLAINT SYSTEM FOR ANY ISSUES OR OTHER COMPLAINTS REPORTED AGAINST DEVICES DISTRIBUTED FROM LOT S10872. RESULTS OF EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS RESULTED IN NO REMARKABLE FINDINGS. (B)(4). CONCLUSION: PRESENCE OF INFECTION MAY HAVE CONTRIBUTED TO DEVICE DISINTEGRATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL THAT THE PATIENT UNDERWENT SURGERY FOR VENTRAL HERNIA REPAIR AND REMOVAL OF INFECTED MESH ON (B)(6) 2011. STRATTICE WAS USED AS AN ONLAY. TWO DRAINS WERE USED. THE PATIENT DEVELOPED A FEVER 4-5 DAYS POST-OPERATIVELY AND SHOWED OTHER SIGNS OF INFECTION. ON (B)(6) 2011, THE PATIENT REQUIRED A SECOND SURGERY DUE TO WOUND DEHISCENCE AND SURGEONS DISCOVERED THAT THE STRATTICE WAS DISINTEGRATED. THE PATIENT WAS TREATED WITH WOUND VAC AND DISCHARGED. THE PATIENT IS BEING FOLLOWED REGULARLY AND THE WOUND IS HEALTHY WITH HERNIA INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 1620002EU S10872-228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention