BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHESTER MEC POP-ON I 30BX

    MDR report key: 9918357 · Received April 2, 2020

    Report

    Report Number
    1018233-2020-02336
    Event Type
    Injury
    Date Received
    April 2, 2020
    Report Date
    April 27, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741070563
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "PLC FAILURE". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND 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." SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ENDED UP WITH AN INFECTION DUE TO URINE THAT BACKED UP INTO THE MALE EXTERNAL CATHETER.

    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 PATIENT ENDED UP WITH AN INFECTION DUE TO URINE THAT BACKED UP INTO THE MALE EXTERNAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381303 ROCHESTER MEC POP-ON I 30BX MALE EXTERNAL CATHETER NNX C.R. BARD, INC. (COVINGTON) -1018233 32303 UNK 00801741070563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other