BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB

    MDR report key: 594170 · Received April 7, 2005

    Report

    Report Number
    3004028675-2005-00003
    Event Type
    Other
    Date Received
    April 7, 2005
    Date of Event
    March 5, 2005
    Report Date
    April 7, 2005
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLOSURE OF A 16CM INCISION (HIP FRACTURE). NO SUPPORTING SUTURES UTILIZED TO RELIEVE EXCESSIVE TENSION ON THE WOUND EDGES PRIOR TO DEVICE USE. THE WOUND LOOKED SATISFACTORY IMMEDIATELY POST-OP. THE WOUND EXPERIENCED A GREAT DEAL OF SWELLING AND EDEMA IN THE INITIAL 3 DAYS POST-OP. PARTIAL (APPROXIMATELY 5-6 CM) DEHISCENCE OCCURRED ON POST-OPERATIVE DAY 3 REQUIRING SURGICAL INTERVENTION FOR RE-CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB SKIN STAPLER GDW INCISIVE SURGICAL, INC. INSORB 20 044801 OR 044802

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R