BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MEC ULTRAFLEX M 30BX

    MDR report key: 6110412 · Received November 17, 2016

    Report

    Report Number
    1018233-2016-01643
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    ROCHESTER MEDICAL CORP 2130787
    Product Code
    NNX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    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. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "GENTLY ROLL CATHETER OFF THE PENIS. NOTE: IF NECESSARY, APPLY A WARM WET COMPRESS (SUCH AS A WET WASHCLOTH) AROUND THE CATHETER TO HELP LOOSEN THE ADHESIVE."(B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SKIN ALLEGEDLY TORE WHEN REMOVING THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SKIN ALLEGEDLY TORE WHEN THE CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759807 ROCHESTER MEC ULTRAFLEX M 30BX MEC NNX ROCHESTER MEDICAL CORP 2130787 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1