BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3C0600 - CURE PRODUCTS

    MDR report key: 15051245 · Received July 19, 2022

    Report

    Report Number
    1049092-2022-00312
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Manufacturer
    CONVATEC INC
    Product Code
    GBM
    UDI-DI
    00815947021106
    PMA / PMN Number
    K072539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: CATHETER URETHERAL. 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 · 0

    CONSUMER REPORTS USING QTY 1 ULTRAM12C FROM A SAMPLE PACK, LOT # 210813-3 AND IT "FELT SHARP" IN URETHRA. THIS WAS HIS FIRST TIME TRIALING THIS CATHETER. HE SAID IT FELT SHARP IN HIS URETHRA ALL THE WAY IN THE INSERTION AND REMOVAL OF THE CATHETER. HE HAS NO ALLERGIES HE IS AWARE OF TO LUBRICANT OR OF ANY KIND. HE SAID IT FELT SHARP, "LIKE IT WAS DIGGING INTO HIS URETHRA." NO SHARP EDGES, ABNORMALITIES HE COULD SEE OR NOTED AT ALL WITH THE CATHETER ITSELF. HE MENTIONED HE HAS VERY POOR EYESIGHT AND THIS CATHETER IS COATED IN LUBRICANT WHICH WOULD HAVE MADE IT HARD TO SEE/ NOTATE ABNORMALITIES. HE SAID IT FELT LIKE THE "FRONT LEADING EDGE" UP NEAR THE EYELETS IS WHERE THE FELT THE SHARPNESS MORE. HE SAID THE DISCOMFORT ENDED AS SOON AS THE CATHETER WAS REMOVED. DENIES ANY BLEEDING. NO MEDICAL INTERVENTION SOUGHT. HE HAS NOT HAD THIS FEELING OCCUR WITH OTHER CATHETERS. HE SAID THE LUBRICANT ITSELF FELT DRY AND THICK COMPARED WITH MULTIPLE OTHER CATHETERS HE HAS TRIALED AND HE DID NOT LIKE IT. HE DID PLACE THE CATHETER IN WITH THE COUDE TIP CORRECTLY POINTING UPWARDS, MAKING SURE BLUE LINE WAS UPWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261249 L3C0600 - CURE PRODUCTS GBM CONVATEC INC 510813 210813-3 00815947021106

    Patients

    Seq Age Sex Outcome Treatment
    1 76 Male