BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1895009 · Received November 5, 2010

    Report

    Report Number
    2953144-2010-02727
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST DEPLOYMENT OF A STARCLOSE SE CLIP IN AN UNSPECIFIED VESSEL AFTER A DIAGNOSTIC PROCEDURE, THE PT REPORTED A RASH ALL OVER HER EXTREMITIES. THE START DATE OF THE RASH WAS NOT SPECIFIED. AT THE TIME OF THE PROCEDURE, THE PT DID NOT REPORT AN ALLERGY TO METAL. IT WAS REPORTED THAT THE PT WAS REFERRED TO AN ALLERGIST BY HER CARDIOLOGIST. TREATMENT OF THE RASH, IF ANY, WAS NOT PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFO REGARDING THE PT OR POSSIBLE TREATMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other