BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE FOLEY CATHETER

    MDR report key: 3961177 · Received July 23, 2014

    Report

    Report Number
    MW5037446
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 22, 2014
    Manufacturer
    MEDLINE
    Product Code
    NWR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON PLACEMENT AND INFLATION, THE Y BALLOON SITE DISASSEMBLED, LEAVING BALLOON Y PORT WITHOUT FUNCTION. DIAGNOSIS OR REASON FOR USE: LABOR AND DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432087 SILICONE FOLEY CATHETER FOLEY CATHETER NWR MEDLINE

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention