BEUDAMED
    FDA Adverse Event Summary report: N

    INSORB SKIN STAPLER

    MDR report key: 3981330 · Received July 24, 2014

    Report

    Report Number
    3004028675-2014-00008
    Date Received
    July 24, 2014
    Date of Event
    January 1, 2013
    Report Date
    June 3, 2014
    Manufacturer
    INCISIVE SURGICAL
    Product Code
    GDT
    PMA / PMN Number
    K120373
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PT UNDERWENT A TOTAL KNEE ARTHROPLASTY PROCEDURE. A HEMATOMA DEVELOPED AND WAS EXPELLED RESULTING IN A WOUND SEPARATION. THE PT WAS TREATED WITH LOCAL ANESTHESIA AND RECLOSED WITH SUTURE IN A CLINIC OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435422 INSORB SKIN STAPLER SKIN STAPLER GDT INCISIVE SURGICAL 2030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention