BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE PRODUCTS

    MDR report key: 15986267 · Received December 15, 2022

    Report

    Report Number
    1049092-2022-00535
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Report Date
    December 9, 2022
    Manufacturer
    CONVATEC INC
    Product Code
    EZD
    UDI-DI
    20815947020349
    PMA / PMN Number
    K132500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CATHETER, STRAIGHT, PROCODE: EZD. 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: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    END USER REPORTS THE CATHETERS "ARE ALREADY STICKING IN THE PACKAGING NEARLY "50% BONDED TO PACKAGE" EVEN BEFORE ACTIVATION HE DOES NOT USE THEM. HE SAID EVEN AFTER ACTIVATION THESE WILL "RIP PAPER FIBER" WHEN HE GOES TO REMOVE THEM. HIS CONCERN IS ALSO THAT THESE CATHETERS HAVE A "SHARP EDGE" ONCE UNGLUED TO PACKAGING ON THAT AREA THAT WAS STUCK ALONG WITH PAPER FIBERS. HE ALSO NOTES THAT THE AREA NEAR THE TIP IS UNCOMFORTABLE AS THE COATING AFTER ACTIVATION CAN LOOK LIKE "LUMPS, CHUNKS, GRAINS OF SUGAR" WHICH MAKES THE TIP UNCOMFORTABLE IF USED. HE SAID HE HAS USED 10 X MAGNIFICATION AND HE SAID HE THINKS IT'S BECAUSE THE HYDROPHILIC COATING IS INITIALLY PLACED UNEVENLY. HE SAID HE KNOWS IT'S THE COATING AS HE HAS LET THEM DRY JUST TO OBSERVE THEM AND DOES NOT USE THEM AND HE SAID THESE LUMPS DISAPPEAR AND DRY OUT. LAST WEEK HE DID END UP USING ONE THAT WAS STUCK TO PACKAGING AND HE SAID HE "REGRETS IT". HE STARTED TO FEEL SHARP PAIN WITH INSERTION AS THE COATING CREATED A SHARP EDGE TO THE CATHETER. PAIN WENT AWAY AFTER USE, NO INTERVENTIONS NEEDED." A SEPARATE CASE HAS BEEN CREATED FOR THE "RIP PAPER FIBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513980 CURE PRODUCTS CATHETER, STRAIGHT EZD CONVATEC INC HM14C 220528-3 20815947020349

    Patients

    Seq Age Sex Outcome Treatment
    1 67 Male