BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDICATH CH10 FEMALE

    MDR report key: 1993969 · Received February 16, 2011

    Report

    Report Number
    3003814961-2011-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Report Date
    January 20, 2011
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    PMA / PMN Number
    K023254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED BUT AS OF TO DATE NO PRODUCT WAS RETURNED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURENCE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4). ACCORDING TO THE INFORMATION RECEIVED, A NURSE OPENED A BOX OF CATHETERS LABELLED 10 FRENCH BUT DISCOVERED THAT THE CATHETERS WERE 12 FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDICATH CH10 FEMALE INTERMITTENT CATHETER GBM COLOPLAST A/S 2851001001 2620109

    Patients

    Seq Age Sex Outcome Treatment
    1