BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-QUR MESH

    MDR report key: 8566864 · Received April 30, 2019

    Report

    Report Number
    3011175548-2019-00489
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 25, 2019
    Report Date
    April 30, 2019
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    UDI-DI
    00650862315448
    PMA / PMN Number
    K050311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS REMOVED FROM THE SHIPPING BOX AND INSPECTED. UPON INSPECTION THE POUCH APPEARED TO HAVE BEEN OPENED FROM THE SIDE OF THE SEALED POUCH AND THE POUCH WAS RIPPED INTO THE MIDDLE OF THE POUCH. THE POUCH WAS ATTEMPTED TO BE OPENED FROM THE TOP OF THE PACKAGE AND IT OPENED PROPERLY AND WITHOUT ISSUE. THE MESH WAS STILL INSIDE THE POUCH WITH THE PROTECTIVE FILM STILL COVERING THE MESH. THERE WERE NO SIGNS OF PARTICULATE ON THE PROTECTIVE FILM OR UPON THE UNDERLYING MESH. IT IS NOT KNOWN HOW OR WHY THE MESH POUCH WAS TORN IN SUCH A MANNER. THE DETAILS INDICATED THAT THE ADHESIVE WAS DEFECTIVE. A REVIEW OF THE ADHESIVE BOND SHOWED NO DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THIS LOT OF MESH PASSED ALL QUALITY AND PERFORMANCE REQUIREMENTS. A REVIEW OF THE COMPLAINT HISTORY SHOWS THAT THERE HAVE BEEN NO OTHER COMPLAINTS FOR THIS LOT OF MESH IN REGARDS TO THE PACKAGING OPENING IMPROPERLY. SUMMARY/CONCLUSION: BASED ON THE DETAILS OF THE COMPLAINT, ATRIUM MEDICAL CANNOT CONCLUDE THAT THE MESH PACKAGING WAS FAULTY.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF THE INVESTIGATION INTO THIS EVENT.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT THEY WENT TO OPEN THE PACKAGE ON THE STERILE FIELD FOR SURGERY THE ONE SIDE OF THE PACKAGE WOULD NOT OPEN CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360629 C-QUR MESH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31544 438312 00650862315448

    Patients

    Seq Age Sex Outcome Treatment
    1