BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB

    MDR report key: 2312860 · Received October 26, 2011

    Report

    Report Number
    MW5022848
    Event Type
    Malfunction
    Date Received
    October 26, 2011
    Date of Event
    October 17, 2011
    Report Date
    October 25, 2011
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSORB SUBCUTICULAR SKIN STAPLER MISFIRED AFTER C-SECTION GOING INTO SKIN SURFACE RATHER THAN UNDERNEATH OR GOING INTO ONE SIDE OF THE SUB-Q. USED A SECOND STAPLER & SUTURE TO CLOSE REST OF INCISION. PT HAD BRUISING ALONG INCISION SITE DUE TO EXTRA MANIPULATION AND PUNCTURE FROM STAPLES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB INSORB SUBCUTICULAR SKIN STAPLER GDT INCISIVE SURGICAL, INC. 112701

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR