BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERMITTENT

    MDR report key: 8653633 · Received May 30, 2019

    Report

    Report Number
    3005778470-2019-00030
    Event Type
    Injury
    Date Received
    May 30, 2019
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    PMA / PMN Number
    K896729
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE CORRECTED FROM 08/30/2017 TO 09/05/2017. THE PRODUCT WAS MANUFACTURED UNDER PRODUCT SPECIFICATION. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER MATERIAL IDENTIFICATION 1300050 AND MANUFACTURING LOT NUMBER 7H06076 IN C2. LOT NUMBER 7H06076 WAS PACKED FROM 5TH TO 17TH SEPTEMBER 2017 ON PACKAGING MACHINE P010. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING. LOT 7H06076 WAS STERILIZED UNDER STERILIZATION LOT 25A170912, 26A170920. ACCORDING TO H802009 DURING THE IN PROCESS CONTROL A PEEL PACK IS PLACED UNDER THE WATER TO A DEPTH OF 50MILLMETER TO MONITOR IF AIR BUBBLES EMANATE FROM THE PEEL PACK DURING 10 SECONDS. LEAKAGE OF BUBBLES FROM THE FOIL AND FROM THE SEALING BETWEEN THE PAPER AND FOIL ON ALL PEEL PACKS IS INSPECTED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION PROCESS OF THE MENTIONED LOT. NO SAMPLES OR PHOTO WAS RECEIVED TO THE COMPLAINT. NO DEFECT ON PRODUCT WAS REPORTED. A QUERY WAS RUN AGAINST PART NUMBER 011.14.020 ON JUNE 24TH 2019 WHICH YIELDED ONE OCCURRENCE IN TRACKWISE 8.7. LOT IN QUESTION WAS INCLUDED IN RECALL 2018-005 INITIATED DUE TO THE POTENTIAL FOR A BREACH IN THE STERILE BARRIER. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER, REPORTING SITE: 1049092, MANUFACTURING SITE: 3005778470.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE END USER "WAS SENT THE RECALL NOTICE AND CONTACTED ON APRIL 02, 2019 WHEN SHE WAS SUPPLIED THE REPLACEMENT. SHE STARTED TO EXPERIENCE URINARY INFECTIONS IN (B)(6) 2018, ONCE SHE STARTED TO USE THE CATHETERS. SHE HAD A SEVERE INFLAMMATION OF THE WHOLE PRIVATE AREA AND WAS PUT ON ANTIBIOTICS AND (UNKNOWN) CREAMS AND REFERRED TO A UROLOGIST FOLLOWED BY CYSTOSCOPY AT A HOSPITAL AND EVENTUALLY SENT TO A GYNECOLOGIST. WHILST ON HER HOLIDAYS, SHE HAD FOUR (4) OTHER VISITS TO HEALTH CARE PROVIDERS, BEING PRESCRIBED MORE ANTIBIOTICS FOR URINARY INFECTIONS. SHE IS CURRENTLY ON A REDUCED DOSE OF ANTIBIOTICS FOR THE NEXT SIX WEEKS. THE END USER STATES SHE "BELIEVES THE CONTAMINATED CATHETERS ARE THE CAUSE OF HER PROBLEMS". THE END USER HAD BEEN ON TRIPRIM FROM MID-(B)(6) UNTIL APPROXIMATELY (B)(6) 2019, WITH GAPS IN BETWEEN COURSES AS IT WAS EXPECTED THAT THEY WOULD WORK. SHE THEN HAD A COURSE OF KEFLEX AND AFTER THAT SHE WAS PUT BACK ON TRIPRIM FOR A FULL COURSE BECAUSE, THE INFECTION WAS STILL PRESENT. SHE WAS ASKED TO REDUCE COURSE OF HALF TABLETS DAILY FOR SIX WEEKS. THE END USER DISCONTINUED THE TRIPRIM BECAUSE SHE WAS HAVING PROBLEMS WITH SLEEP FOR WHICH SHE ATTRIBUTED TO THE TRIPRIM, SO SHE DISCONTINUED THEM ALTOGETHER. ADDITIONAL INFORMATION RECEIVED ON (B)(6) AND (B)(6) 2019 FROM THE END USER INFORMING THAT THE CYSTOSCOPY PERFORMED WAS NOT FOR MEDICAL INTERVENTION. THE END USER STATED THAT SHE VISITED HER UROLOGIST ON (B)(6) 2019 AND THE UROLOGIST HAD NOT IDENTIFIED ANY OTHER CHANGES TO HER CONDITION THAT WOULD HAVE LED TO THE PROLONGED INFECTION. SHE IS CURRENTLY FINISHING A DOUBLE COURSE OF KEFLEX AND WILL RETEST A WEEK AFTER COMPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446651 INTERMITTENT CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 011.14.020 7H06076

    Patients

    Seq Age Sex Outcome Treatment
    1