BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIARC

    MDR report key: 1966494 · Received January 13, 2011

    Report

    Report Number
    2183959-2011-00044
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 22, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADD'L INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A MINIARC PRECISE WAS IMPLANTED. AFTER A SUCCESSFUL IMPLANT, THE HOSPITAL STAFF DISCOVERED THE PRODUCT HAD EXCEEDED ITS SHELF LIFE. THE EXP DATE WAS 12/02/2010. AMS INVENTORY TRACKING RECORDS SHOW THAT THE MINIARC WAS DELIVERED TO THE HOSPITAL SITE ON (B)(6) 2010 AND WAS HOSPITAL STOCK UNTIL IMPLANT. THE PRODUCT EXP DATE IS DOCUMENTED ON THE PACKAGING LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIARC SINGLE-INCISION SLING FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other