BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC 3 SELF CATHETER, 14 FR

    MDR report key: 5029081 · Received August 21, 2015

    Report

    Report Number
    MW5055700
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    March 30, 2015
    Report Date
    August 21, 2015
    Manufacturer
    BARD MEDICAL
    Product Code
    MJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT STARTED USING THE MAGIC 3 SELF CATHETERS AFTER HAVING THE STOMACH SURGERY ON (B)(6) 2015. PT USES THE CATHETERS 4 TIMES A DAY. PT IS ON BLADDER STIMULATOR IMPLANTED IN 2006, WHICH IS NOT WORKING WELL AND HAD TO REPLACE 3 TIMES IN THE PAST. IN (B)(6) 2005, PT DEVELOPED UTI AND SAW HER PCP ON (B)(6) 2015, TREATED WITH DOXICILLIN FOR 10 DAYS. PT RECEIVED A RECALL LETTER FROM BARD MEDICAL ON (B)(6) 2015 FOR THE SELF CATHETERS. THE LETTER WAS DATED 07/06/2015. IT SAID TO CALL THE COMPANY BY 08/06/2015 AND ALSO TO RETURN THE CATHETERS. THE PT CANNOT GET THROUGH BECAUSE OF THE HIGH VOLUME CALLS. PT STOPPED USING THE CATHETERS FROM RECALLED LOT NUMBERS. PT SAW HER GYNECOLOGIST AND GAVE A COPY OF RECALL LETTER. PT WILL GIVE A COPY TO HER PCP ALSO. PT HAS 3 BOXES OF RECALLED CATHETERS (30/BOX) AT HOME. CURRENTLY, PT IS USING MAGIC CATHETER FROM DIFFERENT LOT NUMBERS THAT ARE NOT RECALLED. PT STILL HAS DIFFICULT VOIDING AND IRRITATION BUT PT IS FEELING OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554475 MAGIC 3 SELF CATHETER, 14 FR MAGIC 3 SELF CATHETER, 14 FR MJC BARD MEDICAL 73600003
    554476 MAGIC 3 SELF CATHETER, 14 FR MAGIC 3 SELF CATHETER, 14 FR MJC BARD MEDICAL 73600007
    554477 MAGIC 3 SELF CATHETER, 14 FR MAGIC 3 SELF CATHETER, 14 FR MJC BARD MEDICAL 73600021
    554478 BLADDER STIMULATOR BLADDER STIMULATOR EZW UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention