BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIEVE THERMODILATATION KIT

    MDR report key: 1023374 · Received April 2, 2008

    Report

    Report Number
    3005099803-2008-00319
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS NOT BEEN RETURNED YET; THEREFORE, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE REPORTED EVENT. ONCE THE PRODUCT IS RECEIVED, A DEVICE EVALUATION AS WELL AS A DEVICE HISTORY REVIEW WILL BE FORWARDED IN A SUPPLEMENTAL MANUFACTURER'S REPORT.

    Description of Event or Problem · 1

    A PROLIEVE THERMODILATATION KIT WAS USED FOR THERAPEUTIC PURPOSES ON A PT (AGE UNK). DURING THE PROCEDURE, THE PT WAS ANXIOUS AND EXPERIENCED PAIN IN HIS PENIS CAUSING A VASOVAGEL RESPONSE. AS A PRECAUTIONARY MEASURE, THE PHYSICIAN ADMITTED THE PT TO THE HOSPITAL. THERE WAS NO INDICATION OF PT INJURY OR PRODUCT MALFUNCTION. THE PT WAS RELEASED FROM THE HOSPITAL THAT EVENING. SUBSEQUENT TO THE PROCEDURE IN 2008, DURING A FOLLOW UP VISIT, THE PT EXPERIENCED ORCHITIS AND DYSURIA AND WAS RE-ADMITTED TO THE HOSPITAL, AGAIN FOR PRECAUTIONARY MEASURES, AND A COURSE OF TREATMENT WITH ANTIBIOTICS WAS ADMINISTERED. ALTHOUGH THERE HAVE BEEN SEVERAL ATTEMPTS TO GATHER FURTHER DETAILS, THERE IS NO FURTHER INFO REGARDING THIS EVENT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION KIT MEQ BOSTON SCIENTIFIC CORPORATION M0068808022 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention