BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MEC POP-ON I 30BX

    MDR report key: 7292942 · Received February 23, 2018

    Report

    Report Number
    1018233-2018-00525
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Report Date
    February 23, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING RELATED. RECEIVED 3 UNOPENED SPIRIT MECS FOR EVALUATION. THE SAMPLES WERE VISUALLY INSPECTED FOR HOLES OR DAMAGE ON THE PACKAGE, LEGIBILITY OF PRINTED NUMBERS AND LETTERS, EXPIRATION DATE, CORRECT IMPRESSION, PRINT COLOR, MISSING PARTS OF PRINTING, POSITION OF PRINTING, DAMAGED COMPONENT, AND FOREIGN MATTER. THE SAMPLES MET THE ACCEPTANCE CRITERIA. THE VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS. THE SAMPLES WERE FUNCTIONALLY EVALUATED ACCORDING TO THE ALLEGED FAILURE MODE: "STRONG ADHESIVE". THE ACCEPTABLE PEEL STRENGTH MUST BE IN A RANGE FROM 0.60 TO 2.10 LBF . THE RESULTS FOR ALL 3 SAMPLES WERE FOUND OUT OF SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "THE SHEATH IS A STRAPLESS PENILE SHEATH: IS 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 SHEATH 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 BE CHANGED EVERY 24 HOURS FOR REASONS OF HYGIENE. ¿ TO REMOVE: THE SHEATH MAY BE REMOVED BY GENTLY ROLLING IT OFF THE PENIS. AVOID SIMPLY PULLING 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." (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EVALUATION, THE SAMPLES WERE FOUND TO HAVE STRONG ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137296 ROCHESTER MEC POP-ON I 30BX CLEAR ADVANTAGE NNX C.R. BARD, INC. (COVINGTON) -1018233 JUAW0984

    Patients

    Seq Age Sex Outcome Treatment
    1