BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA¿ APDL

    MDR report key: 2991582 · Received March 6, 2013

    Report

    Report Number
    2134265-2013-01518
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, DEVICE REMOVAL DIFFICULTY WAS ENCOURNTERD.THE FLEXIMA DRAINAGE CATHETER WAS INTRODUCED FOR PLEURAL DRAINAGE. DIFFICULTY WAS ENCOUNTERED WHILE TRYING TO REMOVE THE DEVICE REQUIRING THE DEVICE TO BE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95410 FLEXIMA¿ APDL TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001271340

    Patients

    Seq Age Sex Outcome Treatment
    1 Other