BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE FOLEY CATHETER

    MDR report key: 3851170 · Received May 23, 2014

    Report

    Report Number
    1018233-2014-00115
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    January 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDAD DE LA SALUD
    Product Code
    MJC
    PMA / PMN Number
    K984136
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING LABOR AND DELIVERY THE CATHETER COULD NOT BE INSERTED. NO URINE DRAINAGE COULD BE OBTAINED. A CT SCAN SHOWED THAT THE PATIENT EXPERIENCED SOME TYPE OF PERFORATION. EXPLORATORY LAPAROTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309006 SILICONE FOLEY CATHETER MJC PRODUCTOS PARA EL CUIDAD DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention