BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER

    MDR report key: 7009634 · Received November 8, 2017

    Report

    Report Number
    1018233-2017-05762
    Event Type
    Injury
    Date Received
    November 8, 2017
    Report Date
    November 19, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. . THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE LATEX CATHETER PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THAT THE PATIENT EXPERIENCED SWOLLEN GENITALS. THE COMPLAINANT ALLEGED THAT THE NURSES DID NOT NOTICE THAT THE PACKAGING STATED CATHETER CONTAINED LATEX AND INSERTED CATHETER INSIDE PATIENT. THE CATHETER WAS REMOVED AND SWELLING SUBSIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWOLLEN GENITALS. THE COMPLAINANT ALLEGED THAT THE NURSES DID NOT NOTICE THAT THE PACKAGING STATED CATHETER CONTAINED LATEX AND INSERTED CATHETER INSIDE PATIENT. THE CATHETER WAS REMOVED AND SWELLING SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789201 LATEX FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1