BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-QUR V PATCH

    MDR report key: 2640613 · Received June 21, 2012

    Report

    Report Number
    1219977-2012-00014
    Event Type
    Other
    Date Received
    June 21, 2012
    Date of Event
    May 31, 2012
    Report Date
    June 21, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO PRODUCT WAS RETURNED FOR EVAL, THE COMPLAINT CANNOT BE CONFIRMED. FOLLOWING INVESTIGATION, OUR CONCLUSION IS THAT THE PROBABLE ROOT CAUSE IS UNK DUE TO NOT ENOUGH INFO AVAILABLE TO MAKE A DETERMINATION. THE DEVICE HISTORY RECORDS FOR THE BATCH COULD NOT BE REVIEWED DUE TO THE FACT THE PRODUCT CODE OR LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. A REVIEW OF COMPLAINT HISTORY WAS PERFORMED AND THERE WERE NO OTHER SIMILAR INCIDENTS FOUND.

    Description of Event or Problem · 1

    PT PRESENTED WITH RASH/IRRITATION ONE-MONTH POST OP. TREATED WITH ANTIBIOTICS AND ISSUE DID NOT RESOLVE. MESH REMOVED 2 MONTHS POST-OP. RING WAS NOT PART OF MESH. CAME OUT SEPARATELY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization