BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-QUR MESH

    MDR report key: 2519804 · Received March 28, 2012

    Report

    Report Number
    1219977-2012-00007
    Event Type
    Other
    Date Received
    March 28, 2012
    Date of Event
    January 2, 2012
    Report Date
    March 28, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PRODUCT CODE AND LOT NUMBER WERE NOT PROVIDED IN THE LETTER, THEREFORE NO LOT HISTORY REVIEW WAS CONDUCTED. NO CONCLUSION REGARDING THE REPORTED EVENT WAS POSSIBLE WITH THE LIMITED INFORMATION THAT WAS PROVIDED.

    Description of Event or Problem · 1

    PT HAD A VENTRAL HERNIA REPAIR IN (B)(6) 2011 AT (B)(6). PT. STATED, "THERE WERE NO PROBLEMS WITH THIS PROCEDURE OR MESH". ON (B)(6) 2011, WHILE ON HOLIDAY IN (B)(6), PT. EXPERIENCED CONTINUOUS VOMITING. HE WAS ADMITTED TO (B)(6) ON (B)(6) 2011, WITH A DIAGNOSES OF A PARTIALLY BLOCKED COLON AND REACTIVATED HERNIA. PT. HAD INTERVENTIONAL SURGERY ON (B)(6) 2012. MESH WAS TOTALLY DETACHED AND "HAD WRAPPED AROUND A SERIES OF COLONS AND 'STRANGLED' THEM."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other