BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOGEE HC CATHETER 16 FR 16"

    MDR report key: 7273238 · Received February 14, 2018

    Report

    Report Number
    MW5075261
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    December 16, 2017
    Report Date
    February 13, 2018
    Manufacturer
    HOLLISTER INC.
    Product Code
    GBM
    UDI-DI
    1007505228
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I DO SELF CATHETERIZATION 3 TIMES A DAY DUE TO MY NEUROGENIC BLADDER. I HAVE BEEN USING APOGEE HC, HYDROPHILIC INTERMITTENT CATHETER, 16 FR 16 IN, PRODUCED BY HOLLISTER INC. THEY DID WORK VERY WELL WITHOUT SURGICAL LUBRICANT. HOWEVER, THE CATHETERS I RECEIVED ON (B)(6) 2017 SHOWED PROBLEMS. AS USUAL, I FOLLOWED THE INSTRUCTION. BUT THE CATHETER WAS SO STICKY THAT I WAS NOT ABLE TO INSERT AND SLIDE THE CATHETER THROUGH THE URETHRA TO EMPTY THE BLADDER. I NOTIFIED THE PROBLEMS TO MY MEDICAL SUPPLIER AND RETURNED THE PRODUCT. AND I RECEIVED NEW CATHETERS. THEY HAD SAME LOT NUMBERS (1706102 K) AND BAR CODE NUMBERS (B)(4). ANYHOW, I TRIED A FEW OF THEM. THEY HAD SAME PROBLEMS. I WAS ABLE TO USE THEM WITH LARGE AMOUNT OF SURGICAL LUBRICANT. I SUSPECTED THERE MIGHT BE SOME CHEMICAL CHANGES OF THE WATER BAG IN THE CATHETER PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115728 APOGEE HC CATHETER 16 FR 16" APOGEE HC CATHETER 16 FR 16" GBM HOLLISTER INC. 1706102K 1007505228

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR