BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOVEEN NIGHT BAG,2000/140

    MDR report key: 9672878 · Received February 5, 2020

    Report

    Report Number
    3003814961-2020-00001
    Event Type
    Injury
    Date Received
    February 5, 2020
    Report Date
    February 5, 2020
    Manufacturer
    COLOPLAST A/S
    Product Code
    FAQ
    UDI-DI
    00762123030196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, DURING THE NIGHT THE URINE FLOW STOPPED, WHICH CAUSED THE URINE TO "BACK UP INTO HIS BLADDER" AND HEREAFTER HE GOT AN UTI, FOR WHICH HE WAS HOSPITALIZED FOR 8 DAYS AND RECEIVED ANTIBIOTICS. THE PATIENT IS NOW HOME AND RECOVERING. IT IS UNCLEAR WHETHER THE TUBE OF THE URINE BAG, THE MEC OR BOTH WERE TWISTED AND CAUSED THE BLOCKED URINE FLOW. THE USER DESCRIBES THAT HE IS USING THE URINE BAG AS DESCRIBED IN THE IFU, EXPECT FOR WASHING IT WITH BLEACH AND WATER AND RE-USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134950 MOVEEN NIGHT BAG,2000/140 BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, STERILE FAQ COLOPLAST A/S 2134601400 00762123030196

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other