BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1018233-2018-05488

    MDR report key: 8082014 · Received November 16, 2018

    Report

    Report Number
    1018233-2018-05488
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 24, 2018
    Report Date
    December 11, 2018
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 WAS FOUND ADEQUATE AND STATES THE FOLLOWING: "EASY TO USE SOFT ELASTICATED COMFASURE® HAS AN ANTI-SLIP BACKING. IT¿S UNIQUE, EASY-TO-OPERATE RETAINER CLIP SECURES WITH A ¿CLICK¿ - SUPPORTING CATHETER OR DRAINAGE BAG TUBING. EASY TO CHOOSE COMFASURE® IS AVAILABLE IN THREE SIZES. TO DETERMINE THE CORRECT SIZE NEEDED, MEASURE THE CIRCUMFERENCE OF THE WIDEST POINT OF THE THIGH (A) OR ABDOMEN. COMFASURE® IS AVAILABLE ON PRESCRIPTION IN PACKS OF FIVE. OVERNIGHT LINK SYSTEM WHEN YOU GO TO BED AT NIGHT, DO NOT DISCONNECT YOUR LEG BAG FROM THE CATHETER. CONNECT A 2000ML BED BAG (URIPLAN® D813131 OR D1MT) TO THE FLEXIBLE TUBE AT THE BOTTOM OF THE LEG BAG TAP. ONCE THE TWO BAGS ARE SECURELY CONNECTED, OPEN THE TAP OF THE LEG BAG, TO ALLOW OVERNIGHT DRAINAGE OF URINE INTO THE BED BAG. TO SUPPORT YOUR URIPLAN® BED BAG AT NIGHT IT SHOULD BE PLACED ON A FLOOR STAND OR HANGER. URISTAND® IS NOT AVAILABLE ON PRESCRIPTION. CONTACT BARD FOR ORDERING DETAILS.."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BAGS DID NOT EXPAND, SO THE URINE DID NOT FLOW BETWEEN THE POUCHES. THE PATIENT NORMALLY BLOWS INTO THE BAGS BEFORE PUTTING THEM INTO THE UROSTOMY BAG THAT WOULD ALLOW URINE TO FLOW INTO THEM.

    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 BAGS DID NOT EXPAND, SO THE URINE DID NOT FLOW BETWEEN THE POUCHES. THE PATIENT NORMALLY BLOWS INTO THE BAGS BEFORE PUTTING THEM INTO THE UROSTOMY BAG THAT WOULD ALLOW URINE TO FLOW INTO THEM.

    Patients

    Seq Age Sex Outcome Treatment
    1