BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 3592589 · Received December 31, 2013

    Report

    Report Number
    3004028675-2013-00019
    Event Type
    Other
    Date Received
    December 31, 2013
    Date of Event
    January 1, 2010
    Report Date
    December 3, 2013
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDT
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MFR.

    Description of Event or Problem · 1

    A PT UNDERWENT A CESAREAN SECTION AND THE INSORB SKIN STAPLER WAS USED TO CLOSE THE SKIN INCISION. THE PT EXPERIENCE A WOUND INFECTION AT AN UNK TIME POST OPERATION. THE PT WAS READMITTED FOR DEBRIDEMENT, AND HAD AN UNEVENTFUL RECOVERY POST DEBRIDEMENT OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683090 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDT INCISIVE SURGICAL, INC. 2030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention