BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL.

    MDR report key: 8231994 · Received January 9, 2019

    Report

    Report Number
    1018233-2019-00190
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Report Date
    February 27, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741143083
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    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 WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "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".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUCTIONS THAT ACCOMPANIED THE PUREWICK FEMALE EXTERNAL CATHETER DID NOT SPECIFICALLY STATE NOT TO USE ON PATIENTS WHEN THEY ARE SITTING IN A CHAIR. REPORTEDLY, THERE WERE CONCERNS AMONG THE NURSING STAFF BECAUSE THEY HAVE HAD PATIENTS START TO COMPLAIN OF PAIN WHEN SITTING IN CHAIRS AFTER THE CATHETER HAS BEEN PLACED. THE COMPLAINANT STATED THAT SHE WAS UNDER THE IMPRESSION THAT THE PRODUCT WAS FOR BED BOUND PATIENTS ONLY AND WOULD LIKE SOME CLARITY ON THE ISSUE. MSS PROVIDED HER WITH THEIR INSTRUCTIONS FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

    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 INSTRUCTIONS THAT ACCOMPANIED THE PUREWICK FEMALE EXTERNAL CATHETER DID NOT SPECIFICALLY STATE NOT TO USE ON PATIENTS WHEN THEY ARE SITTING IN A CHAIR. REPORTEDLY, THERE WERE CONCERNS AMONG THE NURSING STAFF BECAUSE THEY HAVE HAD PATIENTS START TO COMPLAIN OF PAIN WHEN SITTING IN CHAIRS AFTER THE CATHETER HAS BEEN PLACED. THE COMPLAINANT STATED THAT SHE WAS UNDER THE IMPRESSION THAT THE PRODUCT WAS FOR BED BOUND PATIENTS ONLY AND WOULD LIKE SOME CLARITY ON THE ISSUE. MSS PROVIDED HER WITH THEIR INSTRUCTIONS FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24401 PUREWICK FEMALE EXTERNAL. PUREWICK CATHETER NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741143083

    Patients

    Seq Age Sex Outcome Treatment
    1