BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 3190172 · Received June 17, 2013

    Report

    Report Number
    3004028675-2013-00013
    Event Type
    Other
    Date Received
    June 17, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 4, 2013
    Manufacturer
    INCISIVE SURGICAL
    Product Code
    GDT
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT BREAST REDUCTION PROCEDURE AND THE INSORB 2030 SKIN STAPLER WAS USED TO CLOSE THE SKIN INCISION. THE PATIENT EXPERIENCED A 10 CM WOUND SEPARATION AT 2 DAYS POST OP. WHICH WAS CLOSED IN A CLINICAL SETTING WITH SUTURE UNDER A LOCAL ANESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273932 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDT INCISIVE SURGICAL 2030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention