BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLECATH OTHER

    MDR report key: 17035705 · Received May 31, 2023

    Report

    Report Number
    3005778470-2023-00119
    Event Type
    Injury
    Date Received
    May 31, 2023
    Report Date
    July 20, 2023
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KOD
    UDI-DI
    00768455145522
    PMA / PMN Number
    K172924
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DHR 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. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1706972, GENTLECATH IC TIEM CH12X405MM(1X100PK)US AND MANUFACTURING LOT #2E02498 IN AMOUNT (B)(4) PCS IN JUNE 2022. THE PRODUCT WAS PACKED ACCORDING TO THE INSTRUCTION FOR PACKING G905703 PACKAGING PRODUCTS ON PACKAGING MACHINES. LOT WAS PACKED ON PACKAGING MACHINE P016. PER COMPLAINT "CONSUMER STATES HE GOT A UTI AS HE HAS HAD TO WASH AND REUSE MULTIPLE UNBENT CATHETERS FROM HIS MOST RECENT ORDER OF MONTHLY CATHETERS.¿ THESE ARE SINGLE USE CATHETERS, NOT CATHETERS FOR MULTIPLE USE SO THEY CANNOT BE WASHED AND REUSED AGAIN. THE CATHETERS WERE NOT USED ACCORDING TO IFU 1336288A1. NO OTHER COMPLAINT OF THIS NATURE HAS BEEN RECEIVED ON THE LOT 2E02498. THIS ISSUE WILL BE MONITORED THROUGH CRB AND THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, SOP-000741. 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. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092. MANUFACTURING SITE:3005778470.

    Additional Manufacturer Narrative · 0

    SEX: MALE. AGE: 80 YEARS. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    END USER REPORTS HE WASHES AND REUSES SOME OF THE UNBENT CATHETERS AND RECENTLY GOT A UTI DUE TO THIS PRACTICE HE SAID. HE SAID HE GOT HIS UTI A FEW WEEKS AGO AFTER DOING THIS AND HAD FREQUENCY, URGENCY AND PAIN, WENT IN FOR URINE TESTING WAS POSITIVE FOR UTI AND MD DID PRESCRIBE ANTIBIOTICS FOR THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160940 GENTLECATH OTHER CATHETER, UROLOGICAL KOD UNOMEDICAL S.R.O. 3208182 2E02498 00768455145522

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown