BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR MESH PATCH

    MDR report key: 2476129 · Received January 6, 2012

    Report

    Report Number
    1219977-2011-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2012
    Date of Event
    September 4, 2011
    Report Date
    January 6, 2012
    Manufacturer
    ATRIUM MEDICAL CORP
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE LIMITED INFO PROVIDED, AN EVAL FOR THE DESCRIBED EVENT IS IMPOSSIBLE. THE TYPE OF MESH AND LOT NUMBER WERE NOT IDENTIFIED BY THE REPORTER. MESH COMPLAINTS WERE REVIEWED AND NO SIMILAR EVENTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    PER REPORT RECEIVED BY ATRIUM MEDICAL THROUGH CUSTOMER SATISFACTION SURVEY, THE PT STATED HE RECEIVED A C-QUR MESH PATCH ON (B)(6), 2011 AND BY (B)(6), 2011 IT HAD DISSOLVED IN HIS ABDOMEN AND HAD TO BE REMOVED. HE STATED DURING THE REMOVAL OF THE DEVICE HE GOT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-QUR MESH PATCH FTL ATRIUM MEDICAL CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization