BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCN TUBE

    MDR report key: 22134562 · Received June 3, 2025

    Report

    Report Number
    MW5171058
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    April 16, 2025
    Report Date
    May 14, 2025
    Manufacturer
    UNKNOWN
    Product Code
    LJE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SUBJECT CAME TO THE EMERGENCY DEPARTMENT (ED) ON (B)(6) 2025 BECAUSE SHE ACCIDENTLY PULLED OUT HER PERCUTANEOUS NEPHROSTOMY TUBE (PCN) TUBE ON THE LEFT SIDE. SUBJECT WAS ADMITTED TO THE HOSPITAL FOR TUBAL REPLACEMENT AND WAS DISCHARGED THE FOLLOWING DAY. CRC MADE TREATING PHYSICIAN AWARE OF SAE AND THE TREATING PHYSICIAN ASKED THE SUBJECT ABOUT THE PERCUTANEOUS NEPHROSTOMY TUBE (PCN) TUBE DURING HER FOLLOW UP ON THE NEXT APPOINTMENT. TRIAL TEAM WAS MADE AWARE OF THIS EVENT 12 HOURS AFTER IT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78176 PCN TUBE CATHETER, NEPHROSTOMY LJE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization 5-FLUOROURACIL (5-FU) 400 MG.| LEUCOVORIN CALCIUM 400 MG.| OXALIPLATIN (ELOXATIN) 85 MG.