BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE

    MDR report key: 2103322 · Received May 26, 2011

    Report

    Report Number
    1000306051-2011-00008
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 26, 2011
    Manufacturer
    LIFECELL
    Product Code
    FTM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: TO BE SPECIFIED. REVIEW OF THE DEVICE HISTORY RECORDS: QUERY OF LIFECELL COMPLAINT SYSTEM FOR ANY ISSUES OR OTHER COMPLAINTS REPORTED AGAINST DEVICES DISTRIBUTED FROM LOT S10887. RESULTS OF EVALUATION: TO BE SPECIFIED. REVIEW OF THE DEVICE HISTORY RECORDS RESULTED IN NO REMARKABLE FINDINGS. - AS OF (B)(6) 2011, 156 DEVICES FROM LOT S10887 WERE DISTRIBUTED, INCLUDING TWO DEVICES THAT WERE REPORTED AS IMPLANTED, WITH NO ISSUES OR OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST THIS LOT. BASED ON THE INFORMATION REPORTED AND INTERNAL INVESTIGATION INTO THE COMPLAINT-RELATED LOT, THE DEVICE MAY HAVE CONTRIBUTED TO ADHESION FORMATION WHICH SUBSEQUENTLY CAUSED THE BOWEL OBSTRUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL THAT THE DEVICE WAS IMPLANTED ON (B)(6) 2011 FOR VENTRAL HERNIA REPAIR. TWO WEEKS POST-OPERATIVELY, THE PATIENT DEVELOPED A BOWEL OBSTRUCTION WHICH REQUIRED SURGICAL INTERVENTION. UPON OPENING THE ABDOMEN, THE DEVICE WAS FOUND TO BE ADHERED TO 5-6 CM OF BOWEL AND COLON WAS KINKED. THE DEVICE WAS REMOVED BUT NOT RETURNED FOR ANALYSIS. IT WAS ALSO REPORTED THAT THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL 1016002 S10887-149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention