BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER TRAY, 14F

    MDR report key: 3854013 · Received May 9, 2014

    Report

    Report Number
    1417592-2014-00047
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    January 21, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK MANAGER REPORTED THAT FOLLOWING A C-SECTION, THEY ATTEMPTED TO REMOVE THE FOLEY CATHETER BUT THE BALLOON WOULD NOT DEFLATE. IT REQUIRED A UROLOGY CONSULT FOR REMOVAL. THE RISK MANAGER STATED SHE WOULD NOT DISCLOSE ANY OTHER INFO PERTAINING TO THE INCIDENT. THE SAMPLE WAS RETAINED BY THE FACILITY. IT WAS CONTAINED IN A BAG. THEY ALLOWED IT TO BE VIEWED WHILE IN THE BAG BUT THEY WOULD NOT ALLOW IT TO BE TOUCHED OR MANIPULATED IN ANY WAY. A ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. WE WERE NOT MADE AWARE OF ANY INJURY RESULTING FROM THIS INCIDENT. IT IS NOT KNOWN WHAT INTERVENTION WAS REQUIRED TO DEFLATE THE BALLOON.

    Description of Event or Problem · 1

    THE BALLOON CATHETER WOULD NOT DEFLATE AND REQUIRED A UROLOGY CONSULT FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281792 LATEX FOLEY CATHETER TRAY, 14F NWR MEDLINE INDUSTRIES, INC. 13UB1428

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R