BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL

    MDR report key: 8964704 · Received September 5, 2019

    Report

    Report Number
    1018233-2019-05381
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    October 1, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741151781
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THE REPORTED EVENT COULD BE THAT THE USER DID NOT FOLLOW PROCEDURE FOR ESTABLISHING SUCTION DUE TO WHICH THE SUCTION WAS TOO HIGH, RESULTING IN PATIENT IMPACT, PAIN AND DISCOMFORT. 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: ¿ DO NOT USE THE PUREWICK¿ FEC WITH A BEDPAN OR ANY MATERIAL THAT DOES NOT ALLOW FOR SUFFICIENT AIRFLOW. ¿ TO AVOID POTENTIAL SKIN INJURY, NEVER PUSH OR PULL THE PUREWICK¿ FEC AGAINST THE SKIN DURING PLACEMENT OR REMOVAL. ¿ NEVER INSERT THE PUREWICK¿ FEC INTO VAGINA, ANAL CANAL, OR OTHER BODY CAVITIES. ¿ DISCONTINUE USE IF AN ALLERGIC REACTION OCCURS. ¿ 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¿ FEC ¿ 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¿ FEC. BARRIER CREAM MAY IMPEDE SUCTION. ¿ NOT RECOMMENDED FOR USE ON PATIENTS WITH A KNOWN LATEX ALLERGY. ¿ PROCEED WITH CAUTION IN PATIENTS WHO HAVE UNDERGONE RECENT SURGERY OF THE EXTERNAL UROGENITAL TRACT. ¿ ALWAYS ASSESS SKIN FOR COMPROMISE AND PERFORM PERINEAL CARE PRIOR TO PLACEMENT OF A NEW PUREWICK¿ FEC. ¿ MAINTAIN SUCTION UNTIL THE PUREWICK¿ FEC IS FULLY REMOVED FROM THE PATIENT TO AVOID URINE BACKFLOW." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRY DOC DEVICE SUCTION WAS TO STRONG AND CAUSED THE PATIENT SOME PAIN AND DISCOMFORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRY DOC DEVICE SUCTION WAS TO STRONG AND CAUSED THE PATIENT SOME PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761459 PUREWICK FEMALE EXTERNAL DRY DOC MACHINE NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1