BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORELLE Y CONTOUR MESH

    MDR report key: 5612271 · Received April 25, 2016

    Report

    Report Number
    MW5061918
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Date of Event
    April 7, 2016
    Report Date
    April 7, 2016
    Manufacturer
    COLOPLAST
    Product Code
    OTO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE SURGEON, RESTORELLE Y CONTOUR MESH WAS TEARING DURING APPLICATION WHICH SHOULD NOT BE HAPPENING. THE SURGEON USED RESTORELLE L TO REINFORCE THE PREVIOUS MESH. THE PT HAD NO ILL EFFECTS AS A RESULT OF THE ISSUE WITH THE RESTORELLE Y CONTOUR MESH INITIALLY USED. A SAMPLE OF THE DEFECTIVE PRODUCT WAS SAVED AND WILL BE PROVIDED TO THE MANUFACTURER'S REPRESENTATIVE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. DIAGNOSIS OR REASON FOR USE: UTERO VAGINAL PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259763 RESTORELLE Y CONTOUR MESH RESTORELLE Y CONTOUR OTO COLOPLAST 4801882
    259764 RESTORELLE L MESH RESTORELLE L MESH OTO COLOPLAST

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other