BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLOON CATHETER

    MDR report key: 1374 · Received August 7, 1992

    Report

    Report Number
    2125050-1992-00001
    Event Type
    Injury
    Date Received
    August 7, 1992
    Date of Event
    July 23, 1992
    Report Date
    August 7, 1992
    Manufacturer
    ADVANCED SURGICAL INTERVENTION, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN'S STAFF INDICATED THAT A BALLOON CATHETER WAS INSERTED ON 1/14/91. THIS CATHETER "BURST" AND A SECOND CATHETER WAS INSERTED. DURING SUBSEQUENT VISITS, THE PATIENT COMPLAINED OF IRRITATION IN THE PENIS, AND A "PUSSY-LIKE" FLUID DURING URINATION. EXPLORATION OF THE BLADDER WAS PERFORMED DURING WHICH A SEGMENT OF THE BALLOON CATHETER WAS OBSERVED AND RETRACTED. THERE HAS BEEN NO INDICATION OF INFECTIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON CATHETER DSP ADVANCED SURGICAL INTERVENTION, INC. N/I N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention