BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTOMY ROD STERILE

    MDR report key: 8213566 · Received January 3, 2019

    Report

    Report Number
    3006606901-2019-00002
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    November 12, 2018
    Report Date
    January 3, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZP
    PMA / PMN Number
    K052229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 PATIENT HAD A SUB-ACUTE OPERATION, IMPLANTED A LOOP-ILEOOSTOMY OVER AN OSTOMY ROD ON (B)(6) 2018. PATIENT WAS CHECKED BY A DOCTOR ON (B)(6) 2018, WHERE THE LOOP-ILEOOSTOMY WAS INTACT AND THE OSTOMY ROD WAS PLACED UNDER THE OSTOMY RIDGE. OSTOMY ROD WAS FREELY MOVING. PLAN WAS MADE TO BANDAGE THE STOMA WITH THE OSTOMY ROD. DUE TO THE RUPTURE OF THE FACIE - PATIENT WAS RE-OPERATED ON (B)(6) 2018. DURING THIS OPERATION, IT WAS DESCRIBED THAT THE STOMA HAD A LESION OF THE BACKSIDE. AFTER THE OPERATION, IT WAS DESCRIBED THAT THE STOMA WAS BLEEDING AND THAT THE STOMA HAD "RUPTURED". IT IS NOT KNOWN, IN WHICH SITUATION THE OSTOMY ROD HAS CAUSED DECAY OF THE LOOP-ILEOOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4762 OSTOMY ROD STERILE ROD, COLOSTOMY EZP COLOPLAST A/S 1281201008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other