BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLECATH INTERMITTENT URINARY CATHETER

    MDR report key: 3994343 · Received July 23, 2014

    Report

    Report Number
    3005778470-2014-00047
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    PMA / PMN Number
    K896729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. END USER WENT ON TO REPORT SHE PRODUCT IN USE FOR TWO MONTHS BEFORE THE EVENT OCCURRED. REQUESTED FOR ADDITIONAL INFORMATION HAVE BEEN SENT, AND TO DATE NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT CALLED AND STATED "THAT SHE LET IT GO SEVERAL TIMES BUT, SHE HAS HAD A LOT OF PAIN AND THE CATHETERS SHE RECEIVED DIDN'T HAVE A HOLD IN THE CATHETERS. SHE FURTHER REPORTED, SHE HAD FOUR CATHETERS WITHOUT EYELETS AND SHE WAS SORE FROM CATCHING." NOTE: ISSUE OCCURRED ON TWO (2) SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER ONE (1) CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430981 GENTLECATH INTERMITTENT URINARY CATHETER CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 502034 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1