BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 2772206 · Received October 4, 2012

    Report

    Report Number
    3005099803-2012-04692
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTE: THREE UNRELATED MANUFACTURER REPORTS ARE BEING SUBMITTED TO ADDRESS THE UNKNOWN NUMBER OF EVENTS. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2012-04691, 3005099803-2012-04692 AND 3005099803-2012-04698. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PHYSICIAN HAS EXPERIENCED VERY EARLY BLOCKAGE, SEVERE REACTION AFTER REMOVAL, AND SEVERE IRRITATION REACTION AFTER PROCEDURE (SPECIFICS UNKNOWN) WITH AN UNKNOWN NUMBER OF PERCUFLEX PLUS URETERAL STENTS. ADDITIONAL INFORMATION, INCLUDING PATIENT CONDITION, IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK302

    Patients

    Seq Age Sex Outcome Treatment
    1 Other