BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL

    MDR report key: 8499066 · Received April 10, 2019

    Report

    Report Number
    1018233-2019-01815
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Report Date
    June 14, 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. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A LABELING REVIEW WAS NOT PERFORMED AS THE USER COULD NOT HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUCTION MANUAL WAS NOT IN THE BOX WITH THE DRY DOC.

    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 INSTRUCTION MANUAL WAS NOT IN THE BOX WITH THE DRY DOC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294441 PUREWICK FEMALE EXTERNAL PUREWICK DRYDOC STATION NZU PUREWICK CORPORATION ¿ 3012224959 NA 00801741151781

    Patients

    Seq Age Sex Outcome Treatment
    1