BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTOMY ROD

    MDR report key: 15632752 · Received October 19, 2022

    Report

    Report Number
    3006606901-2022-00020
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    August 1, 2021
    Report Date
    October 19, 2022
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZP
    PMA / PMN Number
    K052229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. A SEPARATE EMDR HAS BEEN FILED UNDER 795105 FOR THE SECOND INDIVIDUAL MENTIONED IN THIS CASE.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, COLOPLAST HAS INITIATED A PMCF STUDY AS AN ONLINE SURVEY COORDINATED BY AN EXTERNAL PARTNER. WHEN COLOPLAST RECEIVED THE FEED-BACK FROM THE SURVEY AN INCIDENT WAS IDENTIFIED, WHERE IT WAS STATED THAT STOMA NECROSIS OCCURRED REPORTEDLY RELATED TO THE USE OF OSTOMY ROD. ACCORDING TO THE AVAILABLE INFORMATION, THIS EVENT WAS RELATED TO HIGH COMPRESSION OF MUCOSA THROUGH THE ROD, RESULTING IN NECROSIS AND EDEMA. SYMPTOMS WERE BLEEDING AND PAIN. OVERALL HEALTH IMPACT WAS CHRONIC PAIN AND REDUCTION OF QUALITY OF LIFE. PRIOR HEALTH CONDITION: CROHN'S DISEASE. NO FURTHER INFORMATION AVAILABLE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2933229 OSTOMY ROD OSTOMY ROD STERILE EZP COLOPLAST A/S 1281401004

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization