BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATANF

    MDR report key: 1724892 · Received June 10, 2010

    Report

    Report Number
    MW5016326
    Event Type
    Injury
    Date Received
    June 10, 2010
    Date of Event
    May 5, 2010
    Report Date
    June 10, 2010
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CAME TO THE EMERGENCY ROOM AND IN THE EMERGENCY ROOM AN ATTEMPT TO PUT A FOLEY CATHETER WAS SUCCESSFUL, BUT IT SEEMS THE FOLEY BALLOON WAS INFLATED IN THE URETHRA AND THE NURSE NOR PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON. THE UROLOGIST WAS CONSULTED AND HE HAD TO MANUALLY POP THE BALLOON WITH A STERILE NEEDLE PASSED THROUGH THE PERINEAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATANF SILICONE FOLEY CATHETER KOD ROCHESTER MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization