BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1061329 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00725
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    ON MAY 15, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALE PT (AGE AND WEIGHT UNKNOWN) WAS SUCCESSFULLY TREATED WITH A PROLIEVE THERMODILATATION KIT IN 2008, AS PART OF A STUDY USING PROLIEVE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). ACCORDING TO THE COMPLAINANT, THE PT EXPERIENCED THE FOLLOWING ANTICIPATED SYMPTOM FOLLOWING HIS TREATMENT WITH PROLIEVE: ERECTILE DYSFUNCTION AT UNSPECIFIED DATES BETWEEN TREATMENT AND AN INTERIM VISIT IN 2008. REPORTEDLY, NO TREATMENT REPORTED, SYMPTOM RESOLVED BY 3 MONTH VISIT IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other