BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX

    MDR report key: 7142325 · Received December 22, 2017

    Report

    Report Number
    1018233-2017-06462
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 4, 2017
    Report Date
    January 10, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741070938
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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: "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 WARMWATER. DRY THOROUGHLY. TRIM PUBIC HAIR IF NECESSARY. UNROLL SELF-ADHERING CATHETER OVER PENIS. GENTLY SQUEEZE THE CATHETER TO PROPERLY SEAL ADHESIVE TO THE SKIN. IMPORTANT: WEAR TIME MAY BE SIGNIFICANTLY REDUCED IF ADHESIVE IS NOT PROPERLY SEALED TO THE SKIN. CONNECT TO DRAINAGE DEVICE. 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). THE DEVICE WAS NOT RETURNED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEETS WERE STICKY WHICH MADE THEM DIFFICULT TO CHANGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHEETS WERE STICKY WHICH MADE THEM DIFFICULT TO CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923906 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX MEC NNX C.R. BARD, INC. (COVINGTON) -1018233 35302 UNK 00801741070938

    Patients

    Seq Age Sex Outcome Treatment
    1