BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETERAL STENT

    MDR report key: 1172098 · Received September 23, 2008

    Report

    Report Number
    3005099803-2008-04782
    Event Type
    Injury
    Date Received
    September 23, 2008
    Report Date
    July 31, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K924600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, THEREFORE, EXPIRATION AND MFG DATES ARE UNK.

    Description of Event or Problem · 1

    NOTE: DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON JULY 31, 2008 THAT A PERCUFLEX STENT WAS USED FOR A URETEROSCOPY ON PT (AGE, GENDER AND WEIGHT UNK). ACCORDING TO THE COMPLAINANT, "THE STENT [WAS] IMPLANTED PAST THE EXPIRATION DATE". IT IS UNK AT THIS TIME WHEN THE DEVICE WILL BE REMOVED. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETERAL STENT FGE BOSTON SCIENTIFIC CORPORATION M0061453690 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other