BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MEC WIDEBAND M 100BX

    MDR report key: 7146314 · Received December 26, 2017

    Report

    Report Number
    1018233-2017-06481
    Event Type
    Malfunction
    Date Received
    December 26, 2017
    Report Date
    January 9, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741070983
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    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 STATES THE FOLLOWING: ¿POP-ON ¿ SELF-ADHERING MALE EXTERNAL CATHETER. WIDEBAND ¿ SELF-ADHERING MALE EXTERNAL CATHETER. SPIRIT ¿ HYDROCOLLOID ADHESIVE SHEATH. DESCRIPTION/INDICATION: 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: WASH PENIS WITH MILD SOAP AND WARM WATER. DRY THOROUGHLY. TRIM PUBIC HAIR IF NECESSARY. OPEN PACKAGE AT PERFORATION. TO REMOVE PLASTIC INSERT, SQUEEZE CATHETER AT THE TOP OF THE WHITE CONE AND PULL TO RELEASE. UNROLL SELF-ADHERING CATHETER OVER PENIS. GENTLY SQUEEZE THE CATHETER TO PROPERLY SEAL ADHESIVE TO THE SKIN. 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.¿ (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS STRONGER THAN USUAL. THE PATIENT REPORTEDLY EXPERIENCED DIFFICULTY REMOVING THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS STRONGER THAN USUAL. THE PATIENT REPORTEDLY EXPERIENCED DIFFICULTY REMOVING THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924865 ROCHESTER MEC WIDEBAND M 100BX MEC NNX C.R. BARD, INC. (COVINGTON) -1018233 36102 UNK 00801741070983

    Patients

    Seq Age Sex Outcome Treatment
    1