BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE

    MDR report key: 7046665 · Received November 20, 2017

    Report

    Report Number
    1018233-2017-06021
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    November 28, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741071577
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    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. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "FITTING THE SHEATH: THE SHEATH IS A STRAPLESS PENILE SHEATH: IT HAS AN ADHESIVE COATING INSIDE TO ENSURE A SAFE AND SIMPLE PROCEDURE FOR FITTING. IF NECESSARY TRIM PUBIC HAIR. CLEAN AND DRY PUBIC AREA. REMOVE SHEATH FROM ITS WRAPPING. PLACE ROLLED END OVER THE END OF THE PENIS, LEAVING A SMALL SPACE BETWEEN THE END OF THE PENIS AND THE CUP OF THE SHEATH IF UNCIRCUMCISED, DO NOT RETRACT THE FORESKIN BUT ALLOW IT TO REMAIN OVER THE GLANS. AVOID CONTACT BETWEEN THE ADHESIVE AND THE GLANS. SLOWLY UNROLL THE SHEATH ALONG THE SHAFT OF THE PENIS, THEN GENTLY SQUEEZE THE SHAD AROUND THE PENIS TO ENSURE EVEN ADHESION. TRY TO AVOID LEAVING A ROLLED 'COLLAR' OF SHEATH AROUND THE BASE OF THE PENIS. FINALLY, CONNECT THE URINE COLLECTION BAG. ALWAYS CHECK THAT THE CONNECTIONS ARE SECURE BEFORE USE. WEAR TIME WILL VARY FROM USER TO USER. IT IS RECOMMENDED THAT A SHEATH B CHANGED EVERY 24 HOURS FOR REASONS OF HYGIENE. TO REMOVE: THE SHEATH MAY BE REMOVED BY GENTLY TOLLING IT OFF THE PENIS. AVOID SIMPLY LULLING THE SHEATH OFF. REMOVING THE SHEATH WHILST HAVING A BATH OR SHOWER MAY INCREASE COMFORT. DO NOT USE ON IRRITATED OR COMPROMISED SKIN. DISCONTINUE USE IF IRRITATION OCCURS." 1420, 2199: "NL".

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT HAD TOO MUCH ADHESIVE; THE ADHESIVE STUCK TO THE PATIENT'S HAIR AND PULLED ON IT MAKING THE PATIENT SORE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT HAD TOO MUCH ADHESIVE; THE ADHESIVE STUCK TO THE PATIENT'S HAIR AND PULLED ON IT MAKING THE PATIENT SORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826402 ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE MEC NNX C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741071577

    Patients

    Seq Age Sex Outcome Treatment
    1