BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MEC POP-ON I 100BX

    MDR report key: 7670716 · Received July 9, 2018

    Report

    Report Number
    1018233-2018-02661
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Report Date
    September 4, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741070495
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURER RELATED. NO DAMAGES WERE NOTED IN THE RETURNED SAMPLES. PER EVALUATION OF SAMPLES, THE ALLEGED COMPLAINT WAS CONFIRMED FOR "STRONG ADHESIVE", SINCE ALL SAMPLES WERE FOUND ABOVE 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 SELF-ADHERING MALE EXTERNAL CATHETER IS DESIGNED FOR THE MANAGEMENT OF MALE URINARY INCONTINENCE. CONTRAINDICATION DO NOT USE ON IRRITATED OR COMPROMISED SKIN. PRECAUTION DO NOT USE IF ALLERGIC REACTION OCCURS. FOR GOOD HYGIENE, CHANGE CATHETER DAILY. USE OF A SINGLE DEVICE FOR LONGER PERIODS THAN 24 HOURS MAY INCREASE THE RISK OF COMPLICATIONS. DIRECTIONS: TO APPLY 1) WASH PENIS WITH MILD SOAP AND WARM WATER. DRY THOROUGHLY. 2) TRIM PUBIC HAIR IF NECESSARY. 3) OPEN PACKAGE AT PERFORATION. 4) TO REMOVE PLASTIC INSERT, SQUEEZE CATHETER AT THE TOP OF THE WHITE CONE AND PULL TO RELEASE. 5) UNROLL SELF-ADHERING CATHETER OVER PENIS. 6) GENTLY SQUEEZE THE CATHETER TO PROPERLY SEAL ADHESIVE TO THE SKIN. 7) CONNECT TO COLLECTION BAG. IMPORTANT: WEAR TIME MAY BE SIGNIFICANTLY REDUCED IF ADHESIVE IS NOT PROPERLY SEALED TO THE SKIN. DIRECTIONS: TO REMOVE 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." CORRECTION: MFR SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INVESTIGATION IT WAS NOTED THAT ALL 6 OF THE SAMPLES TESTED ABOVE THE SPECIFICATION FOR STRONG ADHESIVE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INVESTIGATION IT WAS NOTED THAT ALL 6 OF THE SAMPLES TESTED ABOVE THE SPECIFICATION FOR STRONG ADHESIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511143 ROCHESTER MEC POP-ON I 100BX MEC NNX C.R. BARD, INC. (COVINGTON) -1018233 32103 JUBR0835 00801741070495

    Patients

    Seq Age Sex Outcome Treatment
    1