BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

    MDR report key: 3800920 · Received May 8, 2014

    Report

    Report Number
    3003910212-2014-00012
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FTM
    PMA / PMN Number
    K043056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES IMPLANTED - 12BSGTRI60P/12043713; 12BSGTRI60P/12149772; 12BSGTRI60P/12054121; 12BSGTRI60P/12138202; 12BSGTRI60B/12068151; 12BSGTRI60B/12029306. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE SURGEON ALLEGED THE GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL POSSIBLY CONTRIBUTED TO THE SMALL BOWEL OBSTRUCTION REQUIRING RE-OPERATION TO RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277454 GORE SEAMGUARD® BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL MESH, SURGICAL FTM W.L. GORE & ASSOCIATES 12161254

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention STAPLERS-03/19/2014