BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 30BX

    MDR report key: 7138333 · Received December 21, 2017

    Report

    Report Number
    1018233-2017-06439
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    December 21, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NNX
    UDI-DI
    00801741071348
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 STATES 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 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." (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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ADHESIVE OF THE MALE EXTERNAL CATHETER WAS STICKING TO THE PATIENT AND "MADE HIS SKIN PEEL OFF." NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919053 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 32MM 30BX MEC NNX C.R. BARD, INC. (COVINGTON) -1018233 39303 UNK 00801741071348

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR