BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3923619 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-04040
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    September 4, 2013
    Report Date
    June 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MEDWATCH (B)(4). IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RASH. IN (B)(6) 2013, A 2.50X20MM PROMUS ELEMENT PLUS STENT WAS IMPLANTED. UPON WAKING FROM THE PROCEDURE THE PATIENT NOTED A RASH COVERING THEIR BODY AND ORIFICES. THE PATIENT FOLLOWED UP WITH THEIR CARDIOLOGIST, DERMATOLOGIST AND ALLERGIST BUT THE RASH CONTINUES. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400485 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420250 16195295

    Patients

    Seq Age Sex Outcome Treatment
    1 Other