BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 8270172 · Received January 23, 2019

    Report

    Report Number
    1018233-2019-00375
    Event Type
    Injury
    Date Received
    January 23, 2019
    Report Date
    April 12, 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 EVENT IS CONFIRMED. A POTENTIAL ROOT CAUSE IS THAT THE HEALTHCARE PROVIDER AND/OR PATIENT WERE NOT AWARE THAT THE PATIENT HAD A LATEX SENSITIVITY. NO SAMPLE WAS 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: "NOT RECOMMENDED FOR USE ON PATIENTS WITH A KNOWN LATEX ALLERGY" PATIENT CODE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SKIN IRRITATION DURING USE OF THE PUREWICK EXTERNAL CATHETER. SHE WENT TO HER DOCTOR AND WAS PROVIDED MEDICATION. THE PATIENT HAS A LATEX ALLERGY AND KNEW THAT THE PRODUCT WAS MADE WITH LATEX. SHE STATED THAT SHE WOULD CONTINUE TO USE THE PRODUCT.

    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 EXPERIENCED SKIN IRRITATION DURING USE OF THE PUREWICK EXTERNAL CATHETER. SHE WENT TO HER DOCTOR AND WAS PROVIDED MEDICATION. THE PATIENT HAS A LATEX ALLERGY AND KNEW THAT THE PRODUCT WAS MADE WITH LATEX. SHE STATED THAT SHE WOULD CONTINUE TO USE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64302 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK FEMALE EXTERNAL NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741143083

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention