BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL.

    MDR report key: 10289562 · Received July 17, 2020

    Report

    Report Number
    1018233-2020-04627
    Event Type
    Injury
    Date Received
    July 17, 2020
    Report Date
    July 17, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    NZU
    UDI-DI
    00801741189050
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE MATERIAL SURFACE IS ROUGH, ABRASIVE OR UNCOMFORTABLE THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿WARNINGS: NEVER INSERT THE PUREWICK FEMALE EXTERNAL CATHETER INTO VAGINA, ANAL CANAL OR OTHER BODY CAVITIES. FOR EXTERNAL USE ONLY. DO NOT USE PUREWICK FEMALE EXTERNAL CATHETER WITH BEDPAN OR ANY MATERIAL THAT DOES NOT ALLOW FOR SUFFICIENT AIRFLOW. TO AVOID POTENTIAL SKIN INJURY, NEVER PUSH OR PULL THE PUREWICK FEMALE EXTERNAL CATHETER AGAINST THE SKIN DURING PLACEMENT OR REMOVAL. DISCONTINUE USE IF AN ALLERGIC REACTION OCCURS. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USE INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY OR ILLNESS OF THE PATIENT. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. PRECAUTIONS: NOT RECOMMENDED FOR PATIENTS WHO ARE: AGITATED, COMBATIVE OR UNCOOPERATIVE AND MIGHT REMOVE THE PUREWICK FEMALE EXTERNAL CATHETER. HAVING FREQUENT EPISODES OF BOWEL INCONTINENCE WITHOUT A FECAL MANAGEMENT SYSTEM IN PLACE. EXPERIENCING SKIN IRRITATION OR BREAKDOWN AT THE SITE EXPERIENCING MODERATE/HEAVY MENSTRUATION AND CANNOT USE A TAMPON. DO NOT USE BARRIER CREAM ON THE PERINEUM WHEN USING THE PUREWICK FEMALE EXTERNAL CATHETER. BARRIER CREAM MAY IMPEDE SUCTION NOT RECOMMENDED FOR USE ON PATIENTS WHO HAVE UNDERGONE RECENT SURGERY OF THE EXTERNAL UROGENITAL TRACT. ALWAYS ASSESS SKIN FOR COMPROMISE ND PERFORM PERINEAL CARE PRIOR TO PLACEMENT OF A NEW PUREWICK FEMALE EXTERNAL CATHETER. MAINTAIN SUCTION UNTIL THE PUREWICK FEMALE EXTERNAL CATHETER IS FULLY REMOVED FROM THE PATIENT TO AVOID URINE BACKFLOW. RECOMMENDATIONS: PERFORM EACH STEP WITH CLEAN TECHNIQUE. IN THE HOME SETTING, WASH HANDS THOROUGHLY BEFORE DEVICE PLACEMENT. PRIOR TO CONNECTING THE PUREWICK FEMALE EXTERNAL CATHETER TO HOSPITAL WALL SUCTION TUBING, VERIFY SUCTION FUNCTION BY COVERING THE OPEN END OF THE SUCTION TUBING WITH ONE HAND AND OBSERVING THE PRESSURE DIAL. IF THE PRESSURE DOES NOT INCREASE WHEN THE LINE IS COVERED, VERIFY THAT THE TUBING IS SECURED, CONNECTED AND NOT KINKED. ENSURE THE PUREWICK FEMALE EXTERNAL CATHETER REMAINS IN THE CORRECT POSITION AFTER TURNING THE PATIENT. REMOVE THE PUREWICK FEMALE EXTERNAL CATHETER PRIOR TO AMBULATION. PROPERLY PLACING THE PUREWICK FEMALE EXTERNAL CATHETER SNUGLY BETWEEN THE LABIA AND GLUTEUS HOLDS THE PUREWICK FEMALE EXTERNAL CATHETER IN PLACE FOR MOST PATIENTS. MESH UNDERWEAR MAY BE USEFUL FOR SECURING THE PUREWICK FEMALE EXTERNAL CATHETER FOR SOME PATIENTS. ASSESS DEVICE PLACEMENT AND PATIENT'S SKIN AT LEAST EVERY 2 HOURS. REPLACE THE PUREWICK FEMALE EXTERNAL CATHETER EVERY 8-12 HOURS OR WHEN SOILED WITH FECES OR BLOOD. IF USING WALL SUCTION, CHANGE SUCTION TUBING PER HOSPITAL PROTOCOL OR AT LEAST EVERY THIRTY (30) DAYS. IF USING PUREWICK URINE COLLECTION SYSTEM, REPLACE ACCESSORIES PER PUREWICK URINE COLLECTION SYSTEM USER GUIDE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED THREE URINARY TRACT INFECTIONS (UTI) IN THE LAST SIX WEEKS WHILE USING THE WICKS. AS PER THE ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2020,THE THREE UTIS WERE EACH ABOUT TWO WEEKS APART, AND THE LAST ONE RESULTED IN SEPSIS AND THE PATIENT WAS IN THE HOSPITAL FOR FOUR DAYS. PATIENT IS NO LONGER USING THE PURE WICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753789 PUREWICK FEMALE EXTERNAL. PUREWICK EXTERNAL CATHETER NZU ADAPTEC MEDICAL DEVICES LLC 3014271001 UNK 00801741189050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O