BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXAIR ANTERIOR KIT

    MDR report key: 1709690 · Received June 3, 2010

    Report

    Report Number
    2125050-2010-00009
    Event Type
    Injury
    Date Received
    June 3, 2010
    Report Date
    May 6, 2010
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FTL
    PMA / PMN Number
    K083499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT, SO NO EVALUATION WAS PERFORMED. BECAUSE THE DEVICE REMAINS IMPLANTED AND BECAUSE COLOPLAST'S EXAMINATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF PAIN, COLOPLAST ACCEPTS THE PHYSICIAN'S OBSERVATION OF PAIN AS THE REASON FOR THE MEDICAL INTERVENTION. DEVICE STILL IMPLANTED - NOT RETURNED.

    Description of Event or Problem · 1

    (B) (4).AS REPORTED TO COLOPLAST, A PATIENT EXPERIENCED PELVIC PAIN AT 4 WEEKS AFTER IMPLANT AND IS BEING TREATED WITH PHYSICAL THERAPY FOR 3 MONTHS. THE DEVICE REMAINS IMPLANTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXAIR ANTERIOR KIT SURGICAL MESH FTL COLOPLAST MANUFACTURING US, LLC 5010001400 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention