BEUDAMED
    FDA Adverse Event Other Summary report: N

    CQUR MESH

    MDR report key: 2474234 · Received February 28, 2012

    Report

    Report Number
    1219977-2012-00004
    Event Type
    Other
    Date Received
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT LOT NUMBER AND PRODUCT CODE WAS NOT PROVIDED IN THE REPORT, THEREFORE NO LOT HISTORY RECORD REVIEW WAS CONDUCTED. BASED ON THE LIMITED INFORMATION RECEIVED, NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NO EVENT DETAILS WERE PROVIDED, POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CQUR MESH FTL ATRIUM MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1