BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MEC ULTRAFLEX M 30BX

    MDR report key: 7107885 · Received December 12, 2017

    Report

    Report Number
    1018233-2017-06333
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Report Date
    December 12, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. ALTHOUGH THE PRODUCT FAMILY IS UNKNOWN, THE MALE EXTERNAL CATHETER PRODUCT IFUS ARE FOUND TO BE ADEQUATE BASED ON PAST REVIEWS. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL PATIENTS HAD COMPLAINED THAT THE SHEATH'S ADHESIVE WAS TOO STRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890602 ROCHESTER MEC ULTRAFLEX M 30BX MEC SPIRIT URINALS NNX C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1