BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL

    MDR report key: 8595732 · Received May 9, 2019

    Report

    Report Number
    1018233-2019-02398
    Event Type
    Injury
    Date Received
    May 9, 2019
    Report Date
    June 28, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741143083
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO ¿INADEQUATE MATERIAL SELECTION - MATERIALS OF CONSTRUCTION ARE NOT BIOCOMPATIBLE" CAUSING PATIENT IMPACT, ADVERSE REACTION. 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: "1. CONNECT THE CANISTER TO WALL SUCTION AND SET TO A MINIMUM OF 40MMHG CONTINUOUS SUCTION. ALWAYS USE THE MINIMUM AMOUNT OF SUCTION NECESSARY. IF USING THE DRYDOCTM VACUUM STATION, CONNECT THE CANISTER TO THE UNIT AND TURN THE UNIT ON. PLEASE CONSULT THE DRYDOCTM VACUUM STATION USER GUIDE FOR FURTHER INFORMATION. 2. USING STANDARD SUCTION TUBING, CONNECT THE PUREWICKTM FEMALE EXTERNAL CATHETER TO THE COLLECTION CANISTER. PERI-CARE AND PLACEMENT: 3. PERFORM PERINEAL CARE AND ASSESS SKIN INTEGRITY (DOCUMENT PER HOSPITAL PROTOCOL). SEPARATE LEGS, GLUTEUS MUSCLES, AND LABIA. PALPATE PUBIC BONE AS ANATOMICAL MARKER. 4. WITH SOFT GAUZE SIDE FACING PATIENT, ALIGN DISTAL END OF THE PUREWICKTM FEMALE EXTERNAL CATHETER AT GLUTEAL CLEFT. GENTLY TUCK SOFT GAUZE SIDE BETWEEN SEPARATED GLUTEUS AND LABIA. ENSURE THAT THE TOP OF THE GAUZE IS ALIGNED WITH THE PUBIC BONE. SLOWLY PLACE LEGS BACK TOGETHER ONCE THE PUREWICKTM FEMALE EXTERNAL CATHETER IS POSITIONED. NOTE: PATIENT CAN BE POSITIONED ON BACK, SIDE LYING, FROG LEGGED, OR LYING ON BACK WITH KNEES BENT AND THIGHS APART (LITHOTOMY POSITION) PRIOR TO DEVICE PLACEMENT. MAINTENANCE: 5. TO REMOVE THE PUREWICKTM FEMALE EXTERNAL CATHETER, FULLY SEPARATE THE LEGS, GLUTEUS, AND LABIA. TO AVOID POTENTIAL SKIN INJURY UPON REMOVAL, GENTLY PULL THE PUREWICKTM FEMALE EXTERNAL CATHETER DIRECTLY OUTWARD. ENSURE SUCTION IS MAINTAINED WHILE REMOVING THE PUREWICKTM FEMALE EXTERNAL CATHETER. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. 6. REPLACE THE PUREWICKTM FEMALE EXTERNAL CATHETER AT LEAST EVERY 8-12 HOURS OR IF SOILED WITH FECES OR BLOOD. ALWAYS ASSESS SKIN FOR COMPROMISE AND PERFORM PERINEAL CARE PRIOR TO PLACEMENT OF A NEW PUREWICKTM FEMALE EXTERNAL CATHETER. REMOVAL:"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS HAD TWO URINARY TRACT INFECTIONS IN THE PAST TWO MONTHS AFTER THE USE OF THE PUREWICK DEVICE.

    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 PATIENT HAS HAD TWO URINARY TRACT INFECTIONS IN THE PAST TWO MONTHS AFTER THE USE OF THE PUREWICK DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390100 PUREWICK FEMALE EXTERNAL PUREWICK DEVICE NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741143083

    Patients

    Seq Age Sex Outcome Treatment
    1 Other