BEUDAMED
    FDA Adverse Event Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 4066305 · Received August 26, 2014

    Report

    Report Number
    3004028675-2014-00012
    Date Received
    August 26, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    ONE DAY AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE THE PT EXPERIENCED A WOUND SEPARATION WHICH WAS CLOSED WITH METAL STAPLES IN THE PT'S HOSPITAL ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515597 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDW INCISIVE SURGICAL, INC. 2030 134801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention