BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSORB ABSORBABLE STAPLER

    MDR report key: 4528267 · Received February 11, 2015

    Report

    Report Number
    MW5040768
    Event Type
    Injury
    Date Received
    February 11, 2015
    Date of Event
    February 7, 2015
    Report Date
    February 11, 2015
    Manufacturer
    INCISIVE SURGICAL, INC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A C-SECTION ON (B)(6) 2015. INCISION WAS CLOSED WITH SUBCUTICULAR SKIN STAPLES. ON (B)(6) 2015, INCISION SEPARATED SLIGHTLY AT MIDLINE REQUIRING STERI STRIPS TO KEEP WOUND CLOSED. THIS WAS THE SECOND REPORT BY THE SURGEON OF THIS TYPE OF EVENT HAPPENING IN THE LAST FEW WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100495 INSORB ABSORBABLE STAPLER INSORB ABSORBABLE STAPLER GDW INCISIVE SURGICAL, INC 2030 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention