BEUDAMED
    FDA Adverse Event Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 3890170 · Received June 10, 2014

    Report

    Report Number
    3004028675-2014-00004
    Date Received
    June 10, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 12, 2014
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDT
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    A PT UNDERWENT A HIP ARTHROPLASTY PROCEDURE AND THE INSORB 2030 SKIN STAPLER WAS USED TO CLOSE THE SKIN INCISION. THE SURGEON REPORTED EXCESSIVE DRAINAGE FOR 16 DAYS POST-OP. UNTIL A WASHOUT WAS PERFORMED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340893 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDT INCISIVE SURGICAL, INC. 2030 135001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention