BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 2040210 · Received March 25, 2011

    Report

    Report Number
    3004028675-2011-00002
    Event Type
    Other
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    INCISIVE SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K090159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER. THE CAUSE OF THIS WOUND SEPARATION IS UNCLEAR PRIMARILY DUE TO LACK OF ADDITIONAL INFO. PHYSICIAN CONTINUES TO USE THE PRODUCT IN HER PRACTICE.

    Description of Event or Problem · 1

    FEMALE, PT, EXPERIENCED A WOUND SEPARATION 2 DAYS FOLLOWING A LAPAROTOMY. THE PT HAD THE INCISION RE-CLOSED IN HER HOSPITAL ROOM UNDER LOCAL ANESTHESIA USING METAL STAPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDW INCISIVE SURGICAL 2030 104101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other