BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLITE

    MDR report key: 2484970 · Received January 19, 2012

    Report

    Report Number
    1219977-2012-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    December 10, 2010
    Report Date
    January 19, 2012
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND THE DEVICES MET ALL SPECIFICATIONS. AN EVAL CANNOT BE PERFORMED DUE TO INSUFFICIENT INFO. CUSTOMER COMPLAINTS ARE MONITORED AND TRENDED. MESH COMPLAINTS WERE REVIEWED AND NO SIMILAR EVENTS HAVE BEEN REPORTED. THE PT STATED THAT ATRIUM MEDICAL CORP IS A DAVOL COMPANY AND THIS IS NOT THE CASE. ATRIUM MEDICAL CORP IS IN NO WAY AFFILIATED WITH DAVOL.

    Description of Event or Problem · 1

    PER MAUDE EVENT REPORT ((B)(4)) SUBMITTED BY PT. THE PT STATED THAT IN 2010, HE HAD A LEFT INGUINAL HERNIA SURGERY WHICH THE SURGEON DESCRIBED IN THE POST-OPERATIVE NOTES AS LARGE AND INCARCERATED. THE REPAIR WAS MADE USING A MESH PLUG AND A MESH OVERLAY, THE MESH WAS LISTED AS PROLITE MESH 3¿X3¿ AND PROLITE MESH 3¿ X 6¿. HE STATED INITIALLY HE EXPERIENCED SOME RECOVERY, BUT SOMETIME DURING THE SAME YEAR HE WAS EXPERIENCING INCREASING CHRONIC PAIN BOTH AT THE LOCATION OF THE PLUG, BUT ALSO IN THE LEFT HIP REGION SURROUNDING THE SCAR TISSUE. HE STATED HE HAS BEEN IN CHRONIC PAIN CONTINUOUSLY. HE HAS HAD AN ULTRASOUND AND X-RAYS WHICH HAVE NOT SHOWN ANY DEFECTS. THE PT ALSO STATED THAT HE LOOKED UP ON THE FDA WEBSITE AND NOTED THAT ATRIUM MEDICAL CORP IS A DAVOL COMPANY AND THAT DAVOL HAS PREVIOUSLY HAD A MESH DEVICE RECALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLITE MESH 3" X3" & 3" X 6" FTL ATRIUM MEDICAL CORP. 1000303&1000306 10554008& 10631327

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization