BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIS

    MDR report key: 6145166 · Received December 5, 2016

    Report

    Report Number
    6145166
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 3, 2016
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    PAH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS PERFORMING ROUTINE PROCEDURE USING THE PRODUCT, HE WAS ABLE TO COMPLETE THE FIRST STEP OF THE TECHNIQUE. HOWEVER, WHEN HE ATTEMPTED TO COMPLETE THE SECOND PASS, THE ANCHOR DID NOT ENGAGE. THE ADJUSTING MECHANISM CAME APART. THE FIRST SIDE OF THE DEVICE WAS ANCHORED IN AND DID NOT COME LOOSE. THE DEVICE SPLIT IN TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795905 ALTIS MESH, SURGICAL, SYNTHETIC PAH COLOPLAST MANUFACTURING US, LLC 519650 5076609

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NO| NO OTHER THERAPIES