BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPEEDICATH, ACC CH14 MALE

    MDR report key: 8957230 · Received September 3, 2019

    Report

    Report Number
    3006606901-2019-00013
    Event Type
    Death
    Date Received
    September 3, 2019
    Report Date
    September 3, 2019
    Manufacturer
    COLOPLAST HUNGARY KFT
    Product Code
    GBM
    UDI-DI
    05708932020350
    PMA / PMN Number
    K023254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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, THE END USER DEVELOPED A CYST ON HIS PROSTATE FROM CATHETERIZING, WHICH LED TO SEPSIS AND PASSED AWAY ON TUESDAY (B)(6) 2017 (WE ARE INVESTIGATING THIS DATE AS IT CONFLICTS WITH THE DATE INDICATED FOR START OF USE OF THE PRODUCT) AT (B)(6) HOSPITAL IN (B)(6). DEVICE: COLOPLAST LUBRICATED STRAIGHT 14 FR INTERMITTENT CATHETER - CATHETER WAS IN A GREEN FOIL METAL PACKAGE CONTAINING LIQUID. (NO PRODUCT NUMBER HAS BEEN GIVEN SO WE HAVE USED 28484 FOR THIS COMPLAINT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748493 SPEEDICATH, ACC CH14 MALE CATHETER, URETHRAL GBM COLOPLAST HUNGARY KFT 2848411400 05708932020350

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other