BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE EASE

    MDR report key: 5353597 · Received January 5, 2016

    Report

    Report Number
    MW5059082
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    January 4, 2016
    Report Date
    January 5, 2016
    Manufacturer
    SUTURE EASE, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    "ACCORDING TO MD, WHEN PRODUCT WAS PLACED IN PT FOR FASCIAL CLOSURE, A PART OF THE PLASTIC BROKE OFF IN THE PT." DIAGNOSIS OR REASON FOR USE: SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5489 SUTURE EASE FASCIAL CLOSURE DEVICE GCJ SUTURE EASE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other| R