BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1051087 · Received May 22, 2008

    Report

    Report Number
    3005099803-2008-00524
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; AS IT WAS DISPOSED OFF BY THE USER FACILITY; 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 APRIL 23, 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MALE PATIENT (AGE AND WEIGHT UNKNOWN) UNDERWENT TREATMENT SUCCESSFULLY WITH A PROLIEVE THERMODILATATION KIT ON THE FIRST WEEK OF THE MONTH, AS PART OF A POST-MARKET STUDY USING PROLIEVE FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). ACCORDING TO THE COMPLAINANT, THE PATIENT DEVELOPED A URINARY TRACT INFECTION (UTI) TERMED MODERATE, COMMENCED A DAY PRIOR TO ORIGINAL DATE, RESOLUTION IS PENDING. TREATMENT WAS ADMINISTERED, BUT HAS NOT YET BEEN REPORTED. THE PATIENT ALSO EXPERIENCED THE FOLLOWING ANTICIPATED SYMPTOMS FOLLOWING HIS TREATMENT WITH PROLIEVE. BLADDER SPASMS, TERMED MODERATE, COMMENCED ON ORIGINAL DATE, RESOLUTION PENDING. TREATED WITH TYLENOL. URINARY PAIN, TERMED MODERATE, COMMENCED THE DAY BEFORE, RESOLUTION PENDING. TREATED WITH TYLENOL. URINARY URGENCY, TERMED MODERATE, COMMENCED THE SAME DAY RESOLUTION PENDING. NO TREATMENT REPORTED FOR THIS SYMPTOM. URINARY FREQUENCY, TERMED MODERATE, COMMENCED A DAY AFTER THE ORIGINAL DATE, RESOLUTION PENDING. NO TREATMENT REPORTED FOR THIS SYMPTOM. HEMATURIA, TERMED MODERATE, COMMENCED ON THE SAME DAY, RESOLUTION IS PENDING. TREATMENT WAS ADMINISTERED, BUT HAS NOT YET BEEN REPORTED.

    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 Required Intervention